A clinical trial is a research study involving human volunteers, and is designed to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find effective treatments, and new ways to improve health.
You can search for all studies that are currently enrolling participants at the University of Rochester by typing in keywords in the search box below. If you don’t find a study that interests you right now, consider signing up for our Volunteer Registry, which will notify you of future studies.
Study of Abaloparatide and Bevacizumab in Myelodysplastic Syndromes
Lead Researcher: Jason Mendler
The primary objective of this study is to determine the safety and tolerability of
combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes
(MDS). A secondary objective is to determine the response to treatment (based on bone
marrow and peripheral blood findings). A tertiary objective is to determine the impact
of therapy on health-related quality of life (HRQOL) and patient-reported outcomes
(PRO). A quaternary (scientific) objective is to determine the impact of treatment
on both hematopoietic and stromal cell populations within the bone marrow of MDS patients.
View Study Details
Study of infusion treatment, axicabtagene ciloleucel, for patients with Indolent
Non-Hodgkin Lymphoma
Lead Researcher: Carla Casulo
Axicabtagene ciloleucel is an experimental product made from the subject's own white
blood cells which are genetically modified and grown to fight cancer. Patients will
be infused with axicabtagene ciloleucel to see if their disease responds and if this
product is safe. This study will enroll approximately 160 adult subjects who have
relapsed or refractory Indolent Non-Hodgkin Lymphoma.
View Study Details
A Drug Study of Ibrutinib + Obinutuzumab in Patients with Chronic Lymphocytic Leukemia
(CLL)
Lead Researcher: Paul Barr
This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab,
as a possible treatment for Chronic Lymphocytic Leukemia (CLL).
View Study Details
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood
Units (CBUs)
Lead Researcher: Jane Liesveld
Cord blood is blood from the umbilical cord of a newborn baby. This blood contains
high concentrations of stem cells (cells from which all blood cells develop). This
study is a protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric
and adult patients with blood cancers.
View Study Details
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic
Leukemia
This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent
chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part
1 of the
study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy
regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib
at the
recommended dose determined in Part 1.
View Study Details
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative
Surgeries for Pathologic Fractures of the Femur
The purpose of this study is to look at two different types of surgeries regularly
used for
treating cancer that has spread to and weakened the thigh bone (femur). Because it
is not
known which of these surgeries is best, the investigators will compare the results
of the two
procedures. They are looking to see if differences exist (after surgery) in function,
quality
of life, pain control, and possible complications.
View Study Details
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide,
Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin,
Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
This Phase III, randomized, double-blind, placebo-controlled study will compare the
efficacy,
safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants
with previously untreated diffuse large B-cell lymphoma (DLBCL).
View Study Details
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine
With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
Glasdegib is being studied in combination with azacitidine for the treatment of adult
patients with previously untreated acute myeloid leukemia (AML) who are not candidates
for
intensive induction chemotherapy (Non-intensive AML population).
Glasdegib is being studied in combination with cytarabine and daunorubicin for the
treatment
of adult patients with previously untreated acute myeloid leukemia (Intensive AML
population).
View Study Details
A study evaluating KTE-X19, a cell therapy infusion for leukemia
Lead Researcher: Kristen O'Dwyer
The primary objectives of this study are to determine the safety and effectiveness
of KTE-X19, a cell therapy (infusion) for adult participants with relapsed/refractory
(r/r) B-precursor acute lymphoblastic leukemia (ALL).
View Study Details
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia
Areata
Lead Researcher: Mary Gail Mercurio
This study is designed to select up to two doses of baricitinib (referred to as low
dose and high dose) and assess their efficacy and safety for the treatment of severe
or very severe alopecia areata.
View Study Details
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal
Junction Cancer (FIGHT)
This is a global, randomized, double-blind, controlled study to evaluate the efficacy
of
bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2
selected
Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA
blood
assay demonstrating FGFR2 gene amplification)
View Study Details
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With
Advanced Solid Tumors
Lead Researcher: Marcus Noel
This study will evaluate the safety profile, tolerability, and effectiveness of the
drug BMS-813160 in patients with metastatic colorectal and pancreatic cancers.
View Study Details
A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin
Lymphoma
Lead Researcher: Jonathan Friedberg
This is an open-label clinical trial designed to evaluate the effectiveness and safety
of brentuximab vedotin, a chemotherapy drug, as front-line therapy of Hodgkin Lymphoma
in adults age 60 and above. It will be given as a single treatment (Part A) or in
combination with dacarbazine (Part B), or in combination with bendamustine (Part C),
or in combination with nivolumab (Part D).
View Study Details
A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With
Recurrent or Progressive Glioblastoma Following Initial Therapy
This is a randomized, active-controlled, multicenter, open-label, parallel groups,
Phase 2
study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients
with
recurrent or progressive glioblastoma multiforme (GBM) following treatment with first
line
therapy consisting of surgery and radiation with or without chemotherapy.
View Study Details
A study of Duvelisib, an oral medicine to treat Peripheral T Cell Lymphoma (PTCL)
Lead Researcher: Carla Casulo
This is a multi-center, open-label study of duvelisib (brand name Copiktra), an oral
medicine to treat patients with relapsed or refractory Peripheral T cell Lymphoma
(PTCL).
View Study Details
A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed
Multiple Myeloma
This research study is studying a combination of study drugs as a possible treatment
for
relapsed and refractory Multiple Myeloma. The interventions involved in this study
are
elotuzumab, pomalidomide, bortezomib, dexamethasone.
View Study Details
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to
Severely Active Crohn's Disease
Lead Researcher: Lawrence Saubermann
The purpose of this program is to evaluate the efficacy and safety of guselkumab in
participants with Crohn's disease.
View Study Details
A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children
With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
The purpose of this study is to compare the effect of a blood thinning drug called
Apixaban
versus no administration of a blood thinning drug, in preventing blood clots in children
with
leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase,
and
have a central line (a catheter inserted for administration of medications and blood
sampling)
View Study Details
A Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in
the Treatment of Subjects with Active Crohn’s Disease
Lead Researcher: Lawrence Saubermann
The purpose of this study is to compare the effectiveness of the drug Ustekinumab
to the drug Adalimumab in patients who have moderate to severe Crohn's disease. The
study will test Ustekinumab compared to Adalimumab for 56 weeks. To determine if the
effectiveness of each drug, patients will come to the clinic regularly to meet with
the study team, complete questionnaires, and have blood work completed.
View Study Details
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide,
Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed
Systemic Amyloid Light-chain (AL) Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus
cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone
in
treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
View Study Details
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants
With Diabetic Macular Edema
Lead Researcher: Ajay Kuriyan
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered
at 8-week intervals or as specified in the protocol following treatment initiation,
compared
with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema
(DME).
View Study Details
A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal
to Mild Alzheimer's Disease
This is a phase II, randomized, placebo-controlled, double-blind study to evaluate
the
efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's
disease.
An optional 96-week open-label extension period will be available to participants
who
complete the double-blind treatment period and who, in the judgment of the investigator,
would potentially benefit from open-label RO7105705 treatment.
View Study Details
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared
With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative
Colitis (UC)
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A
compared with vedolizumab and with placebo in the treatment of participants with moderate
to
severe UC. This study will consist of two parts, Part A and Part B. Part A will test
the
induction of clinical remission and Part B will test the durability of clinical remission.
View Study Details
A Study to Test Radium-223 Therapy With Docetaxel Chemotherapy in Patients With Prostate
Cancer
Lead Researcher: Chunkit Fung
The purpose of this study is to compare any good and bad effects of using radium-223
therapy along with docetaxel chemotherapy treatment versus using docetaxel alone.
View Study Details
Abnormal Cervix Cells: CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical
Lesions in Patients With Abnormal Cervical Cells
Lead Researcher: Richard Moore
The main purpose of this study is to determine whether the presence of Human Papillomavirus
(HPV) and certain chemical substances (biomarkers) in cervical cells can help identify
which women with a cytologic diagnosis of AGC have a benign condition and which have
a pre-cancerous condition or an invasive cancer that requires surgical removal. Each
biomarker will be tested in both cervical cells (obtained similar to a Pap specimen)
and tissue (removed during a surgical procedure). Results of the testing will be
compared to see which biomarker or combination of biomarkers is the most accurate
at identifying which women with a cytologic diagnosis of AGC have a benign condition
and which have a pre-cancerous condition or an invasive cancer.
An additional goal of this study is to study DNA (genetic material) recovered from
tissue to determine if there are changes in the DNA that can tell which women with
a diagnosis of AGC have a benign condition and which have a pre-malignant condition
or invasive cancer.
View Study Details
Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric
and Adult Patients With Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin,
carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients
with germ
cell tumors. Active surveillance may help doctors to monitor subjects with low risk
germ cell
tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin,
carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of
tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading.
View Study Details
Acute Myeloid Leukemia (AML): Crenolanib Versus Midostaurin in Newly Diagnosed Subjects
With FLT3 Mutated AML
Lead Researcher: Jane Liesveld
This purpose of this study is to compare the efficacy of crenolanib with midostaurin
administered following induction chemotherapy and consolidation therapy on event-free
survival in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation.
View Study Details
Acute Myeloid Leukemia (AML): Intensive Chemotherapy with or without Glasdegib or
AZA with or without Glasdegib
Lead Researcher: Jane Liesveld
The purpose of this study is to determine if glasdegib is superior to placebo in combination
with azacitidine or cytarabine and daunorubicin in prolonging overall survival in
subjects with untreated AML.
View Study Details
Acute Myeloid Leukemia (AML): Study of Crenolanib vs Midostaurin Following Induction
Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
Lead Researcher: Jane Liesveld
A phase III randomized multi-center study designed to compare the efficacy of crenolanib
with that of midostaurin when administered following induction chemotherapy, consolidation
chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with
FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either
crenolanib in addition to standard first line treatment of AML (chemotherapy and if
eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B).
Potentially eligible subjects will be registered and tested for the presence of FLT3
mutation. Once the FLT3 mutation status is confirmed and additional eligibility is
established, subject will be randomized and enter into the treatment phase.
View Study Details
Acute Myeloid Leukemia (AML): Uproleselan Administered With Chemotherapy Versus Chemotherapy
Alone in Patients With Relapsed/Refractory AML
Lead Researcher: Jane Liesveld
The purpose of this trial is to compare overall survival achieved with uproleselan
administered with chemotherapy versus chemotherapy alone.
View Study Details
ADMET2
Lead Researcher: Anton Porsteinsson
Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled,
masked, 6 month, 10-center randomized clinical trial sponsored by National Institute
of Aging
involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to examine
the
efficacy and safety of methylphenidate as treatment for clinically significant apathy
in AD.
participants. ADMET 2 will enroll participants from real world settings such as outpatient,
nursing
home, and assisted living facilities and will examine the effects of methylphenidate
on apathy and
cognition. ADMET 2 will also conduct careful safety monitoring.
View Study Details
ADNI3
Lead Researcher: Anton Porsteinsson
ADNI3 is not a treatment study. It continues research that began in 2004 (ADNI1) and
will follow people over a five year period using the information collected from thinking
and memory testing, brain imaging, genetics testing, and blood and brain-spinal fluid
testing to help improve the way AD research is conducted. Approximately 1070 - 2000
participants will be enrolled at 59 sites in the US and Canada. Three groups will
be enrolled and evaluated: those with normal thinking and memory, those with mild
cognition problems, and those with mild Alzheimer's disease. The normal thinking cohort
is filled; the study is now only recruiting people with mild cognition problems (MCI)
or mild Alzheimer's disease.
View Study Details
Amyloidosis: A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination
With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone
in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
Lead Researcher: Frank Passero
There are two treatment groups in this study. The study medication will be given in
treatment cycles, and each cycle is 28 days long. Group A: Cyclophosphamide, bortezomib
(VELCADE®) and dexamethasone (CyBorD). Group B: Daratumumab plus cyclophosphamide,
bortezomib (VELCADE®) and dexamethasone (CyBorD)
View Study Details
Amyloidosis: S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary
Amyloidosis
Lead Researcher: Frank Passero
All participants will receive the same study drug. If you decide to participate, you
will receive up to 24 cycles (1 cycles = 28 days) of the study drug, isatuximab, as
an outpatient (meaning you will not be admitted to the hospital to receive study drug.
During the first cycle (or 28 days), you will receive isatuximab on Day 1, 8, 15 and
22 by intravenous (IV) infusion (into your vein). For all other cycles (Cycle 2, up
to Cycle 24), you will receive isatuximab on Days 1 and 15.
View Study Details
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate
Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation
therapy may stop the adrenal glands from making androgens. Radiation therapy uses
high-energy
x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and
radiation
therapy in treating patients with prostate cancer.
View Study Details
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients
With Prostate Cancer That Has Been Removed by Surgery
Lead Researcher: Yuhchyau Chen
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation
therapy to see how well it works compared with antiandrogen therapy and radiation
therapy alone in treating patients with prostate cancer that has been removed by surgery.
Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the
amount of androgen made by the body. Radiation therapy uses high energy x-rays to
kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel,
work in different ways to stop the growth of tumor cells, either by killing the cells,
by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen
therapy and radiation therapy with or without docetaxel after surgery may kill any
remaining tumor cells.
View Study Details
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring
anticoagulation for the treatment of a VTE.
View Study Details
ASPIRE: Treating Children With Atopic Dermatitis (Eczema)
Lead Researcher: Julie Wolf
This study will monitor the effects of ointments, crisaborole and tacrolimus 0.03%,
on patient-reported outcomes (PROs) and caregiver burden in children (ages 5 to 15
years) with atopic dermatitis over a 12 week period of time. The goal of this study
is to detect changes in PROs and caregiver burden during treatment for atopic dermatitis
of moderate or less severity. The study design will allow us to correlate PROs and
caregiver burden with treatment response and disease improvement in children.
View Study Details
Aspirin in Preventing Recurrence of Breast Cancer
Lead Researcher: Kristin Skinner
This randomized phase III trial studies how well aspirin works in preventing the cancer
from coming back (recurrence) in patients with human epidermal growth factor receptor
2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin
is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being
studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence
in patients with breast cancer.
View Study Details
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary
Arterial Hypertension - CATALYST
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo
in
patients with connective tissue disease-associated pulmonary arterial hypertension
to
determine the recommended dose range and evaluate the change from baseline in 6-minute
walk
distance (6MWD) following 24 weeks of study participation.
View Study Details
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
Lead Researcher: Michael Stoner
This study will compare the effectiveness of best available surgical treatment with
best
available endovascular treatment in adults with critical limb ischemia (CLI) who are
eligible
for both treatment options.
View Study Details
Biliary Cancer: Phase 1b PEGPH20 with Cis & Gem; PEGPH20 with Atezolizumab, Cis &
Gem; and compared with Cis & Gem alone in HA-High Subjects with Metastatic Intrahepatic
and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Lead Researcher: Marcus Noel
If you participate in the Run In portion of this study, you will be assigned to one
of two treatment groups. You can be assigned to receive either PEGPH20 plus Cisplatin
and Gemcitabine or PEGPH20 plus Cisplatin and Gemcitabine and Atezolizumab. If you
participate in the Dose Expansion portion of the study, you will be assigned to one
of three different treatment groups. You can be assigned to receive PEGPH20 plus Cisplatin
and Gemcitabine, PEGPH20 plus Cistplatin and Gemcitabine and Atezolizumab or Cisplatin
and Gemcitabine alone.
View Study Details
Biobanking of Rett Syndrome and Related Disorders
The overarching purpose of this study is to advance understanding of the natural history
of
Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders
including
CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT. Although all
these
disorders are the result of specific genetic changes, there remains broad clinical
variation
that is not entirely accounted for by known biological factors. Additionally, clinical
investigators currently do not have any biomarkers of disease status, clinical severity,
or
responsiveness to therapeutic intervention. To address these issues, biological materials
(DNA, RNA, plasma, cell lines) will be collected from affected individuals and in
some cases
from unaffected family members, initial evaluation performed to identify additional
biological factors contributing to disease severity, and these materials will be stored
for
future characterization.
View Study Details
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma
or Ganglioneuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with
newly
diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue
from
patients with cancer in the laboratory may help doctors identify and learn more about
biomarkers related to cancer.
View Study Details
Bladder Cancer: A Study of Enfortumab Vedotin for Patients With Locally Advanced or
Metastatic Urothelial Bladder Cancer (EV-201)
Lead Researcher: Chunkit Fung
If you choose to take part in this study, the study treatment cycle is 28-days. You
will receive treatment with enfortumab vedotin on Day 1, 8, and 15 of each treatment
cycle. Enfortumab vedotin is given as an infusion into a vein (over about 30 minutes).
View Study Details
Bladder Cancer: A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects
With Urothelial Carcinoma
Lead Researcher: Chunkit Fung
The primary purpose of this research study is to assess how metastatic or surgically
unresectable Urothelial Carcinoma with FGF/FGFR alterations responds to treatment
with INCB054828. The other goals of the study are to determine how safe and well tolerated
the study drug, INCB054828, is, and to obtain data to try and identify patients who
would benefit most from INCB054828.
View Study Details
Bladder Cancer: Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
S1605
Lead Researcher: Deepak Sahasrabudhe
The purpose of this study is to estimate complete response at 25 weeks after registration.
View Study Details
Bladder Cancer: Different Strains of BCG With or Without Vaccine in High Grade Non-
Muscle Invasive Bladder Cancer
Lead Researcher: Edward Messing
This study has 3 study groups; Group 1 will receive the usual BCG LIVE (TICE® BCG)
version of BCG in the bladder, Group 2 will receive BCG in the bladder but it will
be the Tokyo-172 version of BCG instead of the BCG LIVE (TICE® BCG) version, and Group
3 will receive a vaccination as an injection under the skin with the Tokyo-172 version
of BCG followed by receiving the Tokyo-172 version in the bladder. A computer will
assign you to treatment groups in the study by chance. This is done by chance because
no one knows if one study group is better or worse than the others. Neither you nor
your doctor will be able to choose your treatment.
View Study Details
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic
Leukemia
This randomized phase III trial studies how well blinatumomab works compared with
standard
combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia
that
has returned after a period of improvement (relapsed). Monoclonal antibodies, such
as
blinatumomab, may interfere with the ability of tumor cells to grow and spread. It
is not yet
known whether standard combination chemotherapy is more effective than blinatumomab
in
treating relapsed B-cell acute lymphoblastic leukemia.
View Study Details
Brain Cancer: Temozolomide With or Without Veliparib in Treating Patients With Newly
Diagnosed Glioblastoma Multiforme
Lead Researcher: Nimish Mohile
This randomized phase II/III trial studies how well temozolomide and veliparib work
and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma
multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth. It is not yet known
whether temozolomide is more effective with or without veliparib in treating glioblastoma
multiforme.
View Study Details
Brain Training to Promote Health in Family Dementia Caregivers
Lead Researcher: Kathi Heffner
The purpose of the study is to determine whether two types of in-home “brain-training”
programs may have beneficial health effects, including reduced stress and improved
immune health, for individuals caring for a loved one (spouse, parent, friend, etc)
who has dementia.
Participation involves completing one of our brain training programs with the use
of a computer at home a few times a week (when convenient for you), over eight weeks.
Experience or skill with computers is not necessary. If you do not own a computer,
one may be provided for you to use during the program period.
View Study Details
Breast cancer: Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel
With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
Lead Researcher: Allison Magnuson
This study has two study groups.
Group 1 will get the usual chemotherapy drugs used for this type of cancer: doxorubicin
and cyclophosphamide, followed by paclitaxel.
Group 2 will get the usual chemotherapy drugs used for this type of cancer: doxorubicin
and cyclophosphamide, followed by paclitaxel plus the chemotherapy drug called carboplatin.
View Study Details
Breast Cancer: Exemestane With or Without Entinostat in Patients With Recurrent Hormone
Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
Lead Researcher: Michelle Shayne
If you choose to be in this study, you will be "randomized" into one of the study
groups described below.
*If you are in group A, you will take entinostat (5 mg) once per week in addition
to your exemestane once per day. If your doctor decides it is best for you to change
your study drug dosing during the study, you will take your doses as instructed by
your doctor.
*If you are in group B, you will take an inactive substance (called a “placebo”) once
per week in addition to your exemestane once per day. If your doctor decides to change
your study drug dosing during the study, you will take your doses as instructed by
your doctor.
View Study Details
Breast Cancer: HOMING Study: Harvest of Circulating Tumor Cells (CTCs) from Patients
with Metastatic Breast Cancer (MBC) using the Parsortix PC1 System
Lead Researcher: Richard Moore
If you participate in this study, you will be asked to allow the study doctor to draw
3 tubes of blood (up to a total of 23mL or 1 1/2 tablespoons of your blood) for the
evaluation of the presence or absence of CTCs and their characterization as well as
to collect information about your health.
View Study Details
Breast Cancer: MK-3475 as Adjuvant therapy for Triple Receptor-Negative Breast Cancer
or Positive Lymph Nodes After Neoadjuvant Chemotherapy - S1418
Lead Researcher: Alissa Huston
The purpose of this study is to compare treated subjects' invasive disease-free survival
of patients with triple-negative breast cancer after neoadjuvant chemotherapy.
View Study Details
Breast Cancer: Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated
High Risk HER2 Negative Primary Breast Cancer (OlympiA)
Lead Researcher: Alissa Huston
The purpose of this study is to compare the addition of olaparib after the usual care
of chemotherapy, surgery, and radiation for your type of cancer. If your cancer is
sensitive to hormone treatment, you may receive hormone drugs as part of usual care.
In this study, you will get either olaparib or placebo, a pill that looks like the
study drug but contains no medication. The use of olaparib could reduce the risk
of your cancer coming back but it could also cause side effects.
View Study Details
Breast Cancer: Phase III study of hormone therapy with or without the study drug (Everolimus)
in high risk hormone receptor positive & HER-2 negative breast cancer (S1207)
Lead Researcher: Michelle Shayne
The purpose of this study is to see whether treatment with everolimus plus hormone
treatment after chemotherapy will increase the time without your cancer returning.
The current standard treatment after chemotherapy is hormone treatment alone. Everolimus
is a drug currently approved for the treatment of patients with advanced or metastatic
kidney cancer or breast cancer. It is considered investigational for non-metastatic
breast cancer patients. In this study you will get hormone treatment with either
everolimus or with placebo (a placebo is a tablet that looks like the active drug,
but has no active drug in it). The combination of hormone-treatment and everolimus
is experimental in patients with breast cancer.
View Study Details
Breast Cancer: Platinum Based Chemotherapy or Capecitabine in Treating Patients With
Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
Lead Researcher: Michelle Shayne
If you participate in this study, you will be randomized to either receive platinum-based
chemotherapy for 12 weeks (you and your doctor will choose between cisplatin or carboplatin)
or you will get the usual approach used for this type of cancer, capecitabine for
18 weeks.
View Study Details
Breast Cancer: Radiation Therapy with the Oral Drug Olaparib
Lead Researcher: Ajay Dhakal
This phase II trial studies how well radiation therapy with or without olaparib works
in treating patients with inflammatory breast cancer. Radiation therapy uses high
energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet
known whether radiation therapy with or without olaparib may work better in treating
patients with inflammatory breast cancer.
View Study Details
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults
With Stage IIB or Stage IIIB-IVB Hodgkin Lymphoma
This randomized phase III trial studies brentuximab vedotin and combination chemotherapy
to
see how well they work compared to combination chemotherapy alone in treating children
and
young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological
substances in brentuximab vedotin may be able to carry cancer-killing substances directly
to
Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride,
bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide,
work in
different ways to stop the growth of cancer cells, either by killing the cells, by
stopping
them from dividing, or by stopping them from spreading. It is not yet known if combination
chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin
lymphoma.
View Study Details
Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients
With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib
and combination chemotherapy works in treating patients with newly diagnosed stage
II-IV
anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab
vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib
and
methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed
for
cell growth. Drugs used in chemotherapy work in different ways to stop the growth
of cancer
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy
is
more effective than crizotinib and combination chemotherapy in treating anaplastic
large cell
lymphoma.
View Study Details
Cancer (Geriatric): Cognitive Rehabilitation For At-Risk Older Cancer Patients Receiving
Chemotherapy: A Pilot Study Evaluating Feasibility And Impact
Lead Researcher: Allison Magnuson
In Phase I all subjects will receive cognitive rehabilitation intervention which includes,
workshops and at-home computer-based cognitive training. In the phase II portion of
the study, depending on the group you are assigned, you may receive cognitive rehabilitation
intervention or usual care. This will help researchers develop a doable approach to
cognitive rehabilitation and see if it helps reduce the risk of developing progressive
cognitive impairments which is a common side effect of chemotherapy.
View Study Details
Cardiac Surgery Peer Recovery Support Program
Lead Researcher: Barbara Olesko
The purpose of the study is to develop and implement an addiction recovery support
program for cardiac surgery patients admitted with a diagnosis of infective endocarditis
and IV drug addiction. Patients admitted to Strong Memorial Hospital will be enrolled.
We will test whether the recovery support model of care improves a person's readiness
to start addiction treatment.
View Study Details
Cellular Dynamics at the Synovium Bone Interface in RA
Lead Researcher: Jennifer Anolik
You will be asked to have an ultrasound and a biopsy of your inflamed synovial tissue
done. Synovial tissue is found in joints, like your knees, wrists and fingers, and
creates synovial fluid, which helps lubricate your joint. Rheumatoid Arthritis (RA)
causes the thin synovial tissue to become inflamed, leading to an accumulation of
synovial fluid which causes swelling and pain.
View Study Details
Chemotherapy study for acute myeloid leukemia (AML)
Lead Researcher: Jane Liesveld
To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin
in the treatment of relapsed or refractory acute myeloid leukemia in patients of all
ages, and in the treatment of newly diagnosed leukemia in those who are older than
65 when diagnosed.
View Study Details
CLEAR: A Study comparing an injection of the drug SP-102 to placebo for low back pain
Lead Researcher: John Markman
This is a double-blind, placebo-controlled research study to compare the level of
pain relief after an injection of SP-102 or placebo in the treatment of a form of
lower back pain, called sciatica.
View Study Details
Colon Cancer: Combination Chemotherapy With or Without Atezolizumab in Treating Patients
With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Lead Researcher: Mohamedtaki Tejani
This study has 2 groups. Group 1 will receive the usual chemotherapy treatment of
FOLFOX plus the drug atezolizumab for 6 months, then patients will take atezolizumab
alone for an additional 6 months. Group 2 will receive the usual chemotherapy which
is FOLFOX for 6 months.
View Study Details
Colorectal Cancer: Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating
Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer
Lead Researcher: Marcus Noel
This study has 3 study groups. A computer will, by chance assign you to one of the
groups in the study. This is done because no one knows if one study group is worse
or better than the others. You will have an equal chance of being in groups 1, 2,
or 3. Group 1 will get FOLFOX and bevacizumab, Group 2 will get atezolizumab alone
and Group 3 will receive FOLFOX and bevacizumab plus atezolizumab. The drugs will
be given by infusion.
View Study Details
Colorectal Cancer: Regorafenib in Adults ≥ 70 Years with Metastatic Colorectal Cancer
Lead Researcher: Mohamedtaki Tejani
The standard treatment for metastatic colorectal cancer usually includes chemotherapy
which can have side effects that are more difficult to tolerate for older patients
with cancer. Regorafenib (a non-chemotherapy option) was recently approved by the
FDA for treatment of patients whose cancer had grown on all standard chemotherapy
agents.
This study is being done among elderly patients, whose cancer has grown on all chemotherapy
agents or who are not able to tolerate chemotherapy, to measure the safety of regorafenib
in the elderly population and to assess how well the drug controls cancer growth.
View Study Details
Colorectal Cancer: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride
in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal
Cancer That Cannot Be Removed by Surgery
Lead Researcher: Marcus Noel
If you decide to participate in this study a computer will assign you to one of the
3 study groups. This is done by chance because no one knows if one study group is
better or worse than the other. Group 1 will receive the study drugs trastuzumab and
pertuzumab. The combination of trastuzumab and pertuzumab is investigational (not
approved by the FDA for treatment of colorectal cancer). These drugs will be given
through a vein on Day 1 of every 21 day cycle. Group 2 will receive the usual chemotherapy,
cetuximab and irinotecan, through a vein on Day 1 of every 14 day cycle. If you are
in Group 2 and your cancer gets worse, you may have the option to receive the same
treatment as Group 1, and be placed into Group 3.
View Study Details
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk
B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
This randomized phase III trial studies how well combination chemotherapy works in
treating
young patients with newly diagnosed B acute lymphoblastic leukemia that is likely
to come
back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase
inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different
ways to
stop the growth of cancer cells, either by killing the cells, by stopping them from
dividing,
or by stopping them from spreading. Giving more than one drug (combination chemotherapy)
and
giving the drugs in different doses and in different combinations may kill more cancer
cells.
View Study Details
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve
Repair
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety
and
functional outcomes for the repair of nerve injuries in the hand.
View Study Details
Comparison of Study Drug and Entiviyo on the treatment of Colitis
Lead Researcher: Lawrence Saubermann
Study participation will last just under a year. Subjects will be randomized to receive
different dosages of either the study drug or Vedolizumab or placebo. Subjects are
required to visit the clinic 13 times for study related procedures. Infusions (IV
hookup) is the method for receiving the study drug.
View Study Details
Connect® MDS/AML Disease Registry
The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights
into
treatment regimens and sequencing of these regimens as they relate to clinical outcomes
of
patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate
molecular and cellular markers that may provide further prognostic classification
and/or
might be predictive of therapy outcomes.
View Study Details
Cooperative Huntington's Observational Research Trial
The purpose of this study is to collect prospective data from individuals who are
part of a
Huntington Disease (HD) family, in order to relate phenotypes between individuals
and
families with each other and genetic factors in order to learn more about HD, develop
potential treatments for HD, and to plan for future research studies of experimental
drugs
aimed at slowing or postponing the onset and progression of HD.
View Study Details
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That
Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
This randomized phase III trial studies how well crizotinib works in treating patients
with
stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has
a mutation
in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK
can make
it very active and important for tumor cell growth and progression. Crizotinib may
stop the
growth of tumor cells by blocking the ALK protein from working. Crizotinib may be
an
effective treatment for patients with non-small cell lung cancer and an ALK fusion
mutation.
View Study Details
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period
will
have improved neurocognitive outcome at 22-26 months compared to placebo
View Study Details
Development of allergies in babies
Lead Researcher: Kirsi Jarvinen-seppo
The purpose of this study is to determine the impact of breast milk immune factors
on allergy risk. The immune system protects us from getting diseases, working throughout
the body, including secretions such as saliva and breast milk and in the normal bacteria
in the stomach and intestines. A baby's immune system develops over time and maybe
impacted by the breast milk they consume. By comparing saliva, breast milk (if applicable)and
stool, we can study differences among a group of infants at higher risk of developing
allergies.
View Study Details
Developmental Impact of NICU Exposures (DINE)
Lead Researcher: Gloria Pryhuber
The DINE study will test the hypothesis that potentially avoidable NICU-based exposures
contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates.
This hypothesis is drawn from the documented impact of phthalate exposure on early
development in term-born children, and the acknowledged presence of these toxic chemicals
in
the NICU. Third trimester in utero exposure to phthalates have been linked to poorer
childhood performance in cognition, motor function, attention, hyperactivity and social
behavior. Phthalate exposure is also associated with altered onset of puberty and
asthma. The
multi-site cohort and approach will clarify the role of NICU-based phthalate exposure
on
high-prevalence clinical outcomes.
View Study Details
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant
Chemoradiation Therapy for Head and Neck Cancer
Lead Researcher: Deepinder Singh
This study is for people with squamous cell carcinoma (skin cancer) and mucositis.
Mucositis is the painful inflammation and ulceration of the mucous membranes lining
the digestive tract, usually as an adverse effect of chemotherapy and radiotherapy
treatment for cancer. This study will assess the efficacy of SGX942 compared to placebo
in decreasing the duration of severe oral mucositis in patients receiving chemoradiation
treatment for the treatment of head and neck cancer.
View Study Details
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age
22-26
months of donor human milk as compared to preterm infant formula as the in-hospital
diet for
infants whose mothers choose not to provide breast milk or are able to provide only
a minimal
amount. Infants will be randomized to receive donor breast milk or formula during
their
hospital stay. Infant's will be followed until they reach 22-26 months of age.
View Study Details
Dupilumab Study
Lead Researcher: Lisa Beck
Our researchers are studying a new medication called dupilumab to determine how it
affects the immune system, water loss in the skin, and the amount of bacteria in the
skin of adults with atopic dermatitis (eczema).The Food and Drug Administration recently
approved dupilumab for the treatment of moderate-to-severe atopic dermatitis.
You will be randomized (like flipping a coin) with a 66% chance of receiving dupilumab
and 33% chance of receiving placebo for 6 weeks. After 6 weeks everyone will receive
10 weeks of dupilumab. Your skin will be checked for bacteria and barrier function
and your immune system will be monitored.
View Study Details
Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer
Control Participants With an Optional Sub-Study: Research Brain MRI
Lead Researcher: Michelle Janelsins-Benton
Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy
and
age-matched control participants. The investigator is trying to better understand
the
prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared
to
the general population as well as what biological mechanisms may play a role in the
development of these difficulties. Patients will be asked to complete six assessments
over
the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized
and
paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only
involve
the collection of a blood sample. An optional sub study is offered after Assessment
1. It
involves a research brain MRI at Assessment 4.5 and cognitive testing and another
research
brain MRI at Assessment 6.
View Study Details
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy
and Heart Failure After Cancer Treatment
This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers
associated
with cardiomyopathy and heart failure after cancer treatment. Studying samples of
blood in
the laboratory from patients receiving dexrazoxane hydrochloride may help doctors
learn more
about the effects of dexrazoxane hydrochloride on cells. It may also help doctors
understand
how well patients respond to treatment.
View Study Details
Efficacy and safety of AbGn-168H in patients with moderate to severe active ulcerative
colitis
Lead Researcher: Lawrence Saubermann
The purpose of this study is to evaluate the safety and effectiveness of the drug
AbGn-168H in patients who have moderate to severe Ulcerative Colitis. The study will
test use of the drug AbGn-168H for 26 weeks. To determine if the drug is safe and
effective, patients will come to the clinic regularly to meet with the study team,
complete questionnaires, and have blood work completed.
View Study Details
Endometrial Cancer: Lenvatinib in Combination With Pembrolizumab Versus Treatment
of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309
Per Merck Standard Convention [KEYNOTE-775])
Lead Researcher: Richard Moore
If you decide to participate in this study, you will be assigned by chance to get
either lenvatinib plus pembrolizumab or doxorubicin or paclitaxel. You will know what
treatment you will be assigned to receive.
View Study Details
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations
(A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well ensartinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1
genomic
alterations that have come back or do not respond to treatment and have spread to
other
places in the body. Ensartinib may stop the growth of tumor cells by blocking some
of the
enzymes needed for cell growth.
View Study Details
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH
Treatment Trial)
This phase II Pediatric MATCH trial studies how well erdafitinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread
to other
places in the body and have come back or do not respond to treatment with FGFR mutations.
Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed
for
cell growth.
View Study Details
Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung
Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)
This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to
observation works in treating patients with stage IB-IIIA non-small cell lung cancer
that has
been completely removed by surgery. Erlotinib hydrochloride may stop the growth of
tumor
cells by blocking some of the enzymes needed for cell growth.
View Study Details
Essential Thrombocythemia: Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects
With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
Lead Researcher: Frank Akwaa
This study has two groups. The first group, Group A, will be treated with ruxolitinib
and placebo and the second group, Group B, will be treated with anagrelide and placebo.
You will be randomly assigned (like flipping a coin) to Group A or Group B. Neither
you nor your Study Doctor can identify which group you will be assigned to. You will
have equal chance of receiving ruxolitinib or anagrelide.
View Study Details
Evaluating URMC's Massive Transfusion Protocol
Lead Researcher: Majed Refaai
The purpose of the study is to evaluate the efficacy of the University of Rochester
Medical
Center's current Massive Transfusion Protocol.
Upon arrival of trauma level one designated patients the treating team evaluates the
patient's injuries. If the patient is initiated under the facilities Massive Transfusion
Protocol and meets other inclusion and exclusion criteria the patient will be enrolled
in the
study. Study procedures include collection of a blood sample following the transfusion
of
each shipment, through shipment 5, of blood products outlined in the current Massive
Transfusion Protocol.
Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic
state through resuscitation. One final blood sample will be collected 24 hours following
the
discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.
Due to the critical need for medical intervention, consent procedure will be waived
at time
of enrollment. An authorized representative for the patient will be identified and
approached
to obtain consent for use of data collected.
View Study Details
Evaluation of the Effects of Age, Prior Exposure, and Previous Vaccination on B Cell
Response to Influenza Vaccine in Healthy Adults and Children
Lead Researcher: Angela Branche
The study will be designed as a prospective surveillance of the immune response to
seasonal
influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration
will
be 5 years, with a participant duration of 6 months. Subjects will receive Fluarix
(GSK)
quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin
(HA), by intramuscular injection in open label fashion on day 0. Blood draws will
occur at
baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the
relationship between first influenza A virus exposure (inferred by age), vaccine history,
and
baseline serum antibody and Memory B cell (MBC) specificity, and the magnitude and
breadth of
the subsequent B cell response to seasonal influenza vaccine in healthy adults and
children.
View Study Details
Exercise Intervention for LGBT Cancer Survivors
Lead Researcher: Nicole Murray
The purpose of this study is to test preliminary efficacy, as well as acceptability
and
feasibility, of a dyadic exercise intervention, the current study will randomize LGBT
cancer
survivors and their non-professional caregivers as dyads to either an individual or
a dyadic
Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will
be
psychological distress. Analyses will involve pre-post comparisons of outcomes across
the
study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention
will
result in greater improvements in psychological distress than an individual intervention.
View Study Details
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients
With Pulmonary Hypertension RANGER
This extended access study will assess the long-term safety and tolerability of bardoxolone
methyl in qualified patients with pulmonary hypertension (PH) who previously participated
in
controlled clinical studies with bardoxolone methyl.
View Study Details
Fatty Liver due to NASH and Obeticholic Acid (Trade name: Ocaliva)
Lead Researcher: Jonathan Huang
Study participation is expected to last between 5-7 years. Participants will be randomized
to take either 10mg, 25mg, or a placebo pill once daily of the study medication. A
liver tissue biopsy is required up to 4 times over the course of the study, and 15
ultrasounds of your belly. Fasting blood work and vital signs will be taken at each
clinic visit. Questionnaires and an EKG of your heart will be periodically done at
clinic visits. All study medication and protocol required procedures are covered by
the clinical trial sponsor.
View Study Details
First-Line Treatment Study for Leukemia: Evaluating the combination of Pevonedistat
and Azacitidine Vs. Azacitidine alone
Lead Researcher: Jane Liesveld
The purpose of this study is to determine whether the combination of pevonedistat
and azacitidine improves event-free survival (EFS) when compared with azacitidine
alone. This study is for patients with Higher-Risk Myelodysplastic Syndromes, Chronic
Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia.
View Study Details
Follow-up Visit of High Risk Infants
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in
which
surviving extremely low birth-weight infants born in participating network centers
receive
neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected
age
(Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data
regarding
pregnancy and neonatal outcome are collected prospectively. The goal is to identify
potential
maternal and neonatal risk factors that may affect infant neurodevelopment.
View Study Details
Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III
Breast Cancer Undergoing Surgery
Lead Researcher: Kristin Skinner
The study is being conducted to determine whether neoadjuvant endocrine therapy with
fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole
when given before surgery to shrink the cancer and stop it from growing. Anastrozole
inhibits tumor growth by reducing the levels of estrogen and has been approved by
the Food and Drug Administration (FDA) of the United States for use after surgery
for postmenopausal women with estrogen receptor positive breast cancer. It is also
considered a standard of care to give anastrozole for a few months before surgery
to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels
of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women
with early stage breast cancer before or after surgery, but is approved by the FDA
for patients with advanced (Stage 4) estrogen receptor positive breast cancer that
has spread to other parts of the body.
View Study Details
Gastric & Gastroesophageal Cancer: A Study of FPA144 Combined With Modified FOLFOX6
in Gastric/Gastroesophageal Cancer (FIGHT)
Lead Researcher: Mohamedtaki Tejani
This study consists of 2 phases. The first phase (Phase 1) of the study will be open
to patients who have gastrointestinal cancer and plan to receive a type of chemotherapy
treatment called mFOLFOX6. The second phase (Phase 3) will include patients who have
gastric or gastroesophageal cancer, whose physician plans to administer chemotherapy
(mFOLFOX6) as therapy, and have a tumor that is FGFR2b positive.
View Study Details
Gastric Cancer: Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal
Junction Adenocarcinoma
Lead Researcher: Mohamedtaki Tejani
A small number of esophagus cancers have too much of the HER2 protein on the surface
of their cells, which can help cancer cells to grow. Having too much of this protein
is caused by having too many copies of the HER2 gene. If you have esophageal cancer
and can’t have surgery, your doctor may have your tumor biopsy samples tested for
the HER2 protein or gene. The study will compare drugs that target HER2-positive
cancers.
View Study Details
Gastric or Gastroesophageal Junction: Study of Pembrolizumab (MK-3475) Plus Chemotherapy
Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal
Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
Lead Researcher: Mohamedtaki Tejani
If you decide to participate in this research study, your study doctor will assign
you to one of three chemotherapy treatments: XP (cisplatin and capecitabine), FP (cisplatin
and 5-FU) or FLOT (docetaxel, oxaliplatin, 5-FU and leucovorin). Once you are assigned
a chemotherapy treatment, you will be assigned by chance to receive either chemotherapy
+ pembrolizumab before and after surgery followed by pembrolizumab only or chemotherapy
+ placebo (look-alike with no active ingredients) before and after surgery followed
by placebo only. You may still be able to continue in the study if you are unable
to have or no longer need surgery. The study doctor will discuss this with you.
You will be assigned by chance to get either pembrolizumab or placebo (a look alike
with no active ingredients). You have a 1 in 2 chance of getting placebo only. Neither
you nor the study doctor will know if you are receiving pembrolizumab or placebo.
View Study Details
Gastrointestinal (pancreas) Cancer: Glufosfamide Versus 5-FU in Second Line Metastatic
Pancreatic Cancer
Lead Researcher: Marcus Noel
Glufosfamide is being compared against Fluorouracil (5-FU). Fluorouracil is approved
by the FDA for use in people with rectal cancer. 5-FU was the drug of choice for pancreatic
cancer before gemcitabine and is still used in multiple regimens such as folfox and
Folfirinox as part of standard of care.
The study drug is made of glucose (a sugar made by the body) and a substance which
damages or kills cancer cells. Cancer cells depend on sugar more than normal cells
do, so the cancer cells may take up more of the study drug than normal cells. This
may allow glufosfamide to attack the cancer cells without causing excessive damage
to the normal cells.
View Study Details
GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to
Studies Based on Apolipoprotein E (APOE) Genotype
The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify
a large
group of people interested in participating in research studies or clinical trials
based in
part on their genetic background. This genetic information will be used to match interested
individuals to studies, providing a recruitment resource to the Alzheimer's scientific
community. Interested individuals should visit www.endALZnow.org/GeneMatch to join
the
GeneMatch program.
View Study Details
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial
Lead Researcher: Jacob Nadler
This is a large pragmatic multicenter trial comparing maintenance of general anesthesia
with
total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane,
or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.
View Study Details
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive
in NICHD
Neonatal Research Network (NRN) centers. The GDB collects observational baseline data
on both
mothers and infants, and the therapies used and outcomes of the infants. The information
collected is not specific to a disease or treatment (i.e., it is "generic"). Data
are
analyzed to find associations and trends between baseline information, treatments,
and infant
outcome, and to develop future NRN trials.
View Study Details
Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer
That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
This phase III ALCHEMIST trial studies genetic testing in screening patients with
stage
IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying
the
genes in a patient's tumor cells may help doctors select the best treatment for patients
that
have certain genetic changes.
View Study Details
GvHD: A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment
of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH1)
Lead Researcher: Jane Liesveld
This is an open-label Study which means that both you and your Study Doctor will know
what Study Drug you are receiving. Eligible subjects will begin treatment at 5 mg
ruxolitinib twice daily. This may be increased to 10 mg twice daily after 3 days depending
on your blood tests.
View Study Details
Gynecologic (Cervical) Cancer: Chemotherapy and Pelvic Radiation Therapy With or Without
Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer
After Radical Hysterectomy
Lead Researcher: Richard Moore
The standard treatment for your type of cervical cancer is cisplatin
chemotherapy plus radiation. The study will determine whether adding chemotherapy
with
carboplatin and paclitaxel (experimental for your type of cervical cancer) to standard
radiation
and cisplatin chemotherapy improves survival without increasing side effects.
View Study Details
Gynecologic (cervical) cancer: Radiation Therapy With or Without Chemotherapy in Patients
With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery
Lead Researcher: Richard Moore
You will get either standard treatment with radiation therapy OR
standard treatment with radiation therapy with the addition of cisplatin chemotherapy.
View Study Details
Gynecologic (endometrial) cancer: Radiation Therapy With or Without Cisplatin in Treating
Patients With Recurrent Endometrial Cancer
Lead Researcher: Richard Moore
Radiation therapy is a cancer treatment that uses radiation beams from outside your
body, or radioactive seeds or pellets placed directly into the tissue to kill cancer
cells.
Radiation therapy alone has not been very effective in treating large tumors that
recur
(come back) in the pelvis, lymph nodes or vagina. Radiation therapy in combination
with weekly treatment with the chemotherapy drug cisplatin has been found to be very
effective in treating patients with advanced cervical cancers. Another purpose of
the
study is to evaluate the side effects of the combination of radiation therapy and
cisplatin.
View Study Details
Gynecologic Cancer (Ovary, Peritoneal): Trametinib in Treating Patients With Recurrent
or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer
Lead Researcher: Richard Moore
In this study, you will get either the trametinib or one of the standard treatments
available. You will not get both at the same time.
View Study Details
Hairy Cell Leukemia: Quality of Life and Clinical Outcomes of Hairy Cell Leukemia
Patients: A Longitudinal Study
Lead Researcher: Clive Zent
If you decide to participate in this study, you will be asked to complete a quality
of life questionnaire every 6 months, either in clinic, online or in your home. This
survey will take approximately 45 minutes to 1 hour to complete.
View Study Details
Head and Neck Cancer: Radiation Therapy With or Without Cisplatin in Treating Patients
With Stage III-IV Squamous Cell Carcinoma of the Head and Neck Who Have Undergone
Surgery
Lead Researcher: Ronald Maggiore
The purpose of this study is to compare two treatment approaches that are currently
used after surgery for head and neck cancer. One approach is to administer radiation
therapy alone. A second approach is to administer radiation therapy along with the
chemotherapy drug, cisplatin.
View Study Details
Head and Neck Cancer: Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation
in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
Lead Researcher: Ronald Maggiore
You will be assigned to one of two possible study drug treatments: pembrolizumab or
placebo in addition to chemoradiation. you have a 1 in 2 chance of getting placebo,
neither you or your study doctor will know which of these you are receiving.
View Study Details
Hearing Study: Sensitivity to Features of Speech Sounds
Lead Researcher: Laurel Carney
The purpose of this study is to better understand the sensitivity of listeners to
the fast changes in frequency or amplitude of sounds that occur in speech. The investigators
are studying ways to manipulate these aspects of sounds in an effort to make speech
sounds more clear.
We are recruiting listeners age 18 to 80, with either normal hearing or hearing loss.
Listeners with hearing loss must similar hearing loss in both ears that is sensorineural
in nature and mild or moderate in severity. All listeners will have their hearing
tested at the beginning of the study.
View Study Details
Herpes Zoster Vaccine in Patients with Chronic Lymphocytic Leukemia and Waldenström
Macroglobulinemia
Lead Researcher: Jonathan Friedberg
The purpose of this study is to measure humoral response 4 weeks after vaccination
with the Shingrix herpes zoster vaccine in patients with CLL and WM undergoing first-line
treatment with BTK inhibitors.
View Study Details
HOPE-Helping Older People Engage
Lead Researcher: Kimberly Van Orden
The purpose of this study is to compare two activities — reflecting on one’s past
(called “life review”) and volunteering in the community (“volunteering”). We are
interested in learning how these activities may improve social connectedness and well-being
among adults age 60 and older. Volunteering involves participate weekly in a flexible
volunteer program with Lifespan that involves a menu of options including helping
at senior centers, co-leading classes, mentoring/tutoring and many other options.
Life review involves participating in a one-year reminiscence program that is self-guided
and involves completing monthly exercises such as writing about one’s memories.
View Study Details
Hydrocortisone for premature babies
Lead Researcher: Carl D'Angio
The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10
days improves survival for premature infants who have a breathing tube. Infants will
either receive hydrocortisone or placebo.
View Study Details
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate and combination
chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome
positive
acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells
by
blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work
in
different ways to stop the growth of cancer cells, either by killing the cells, by
stopping
them from dividing, or by stopping them from spreading. Giving imatinib mesylate and
combination chemotherapy may work better in treating patients with Philadelphia chromosome
positive acute lymphoblastic leukemia.
View Study Details
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Lead Researcher: Deepak Sahasrabudhe
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
View Study Details
Improving Well-Being for Older Adult Family Dementia Caregivers
Lead Researcher: Kathi Heffner
The purpose of the study is to examine the effects of the Mindfulness-Based Stress
Reduction (MBSR) program and the Living Well (LW) for Dementia Caregivers program,
compared to any usual care, to see if the programs might be associated with better
immune function, physical and emotional health, and well-being.
This study is looking for individuals age 55 and up who are caring for a loved one
(such as a spouse, parent, close friend) who has dementia. Participation includes
attending a weekly small group meeting over eight weeks for one of two study programs
(determined randomly). Both programs address ways of improving physical and emotional
well-being in the context of dementia caregiving. These 8-week programs typically
begin in late August at Monroe Community Hospital.
View Study Details
Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer
Based on EBV DNA
There are two study questions we are asking in this randomized phase II/III trial
based on a
blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally
advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard
concurrent chemotherapy and radiation therapy. When this standard treatment is completed,
if
there is no detectable EBV DNA in their plasma, then patients are randomized to either
standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there
is still
detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin
and
fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses
high
energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin,
fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to
stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by
stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil
is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy
in
treating patients with nasopharyngeal cancer.
View Study Details
Induction Chemotherapy for Locally Advanced Esophageal Cancer
Lead Researcher: Mohamedtaki Tejani
Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction
treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant
recurrence among patients with locally advanced esophageal cancer.
View Study Details
Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
Lead Researcher: Richard Dunne
Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve
EGFR inhibitor-induced rash. Epidermal growth factor receptor (EGFR) inhibitors have
been used to treat a variety of cancers, including head and neck cancer, non–small-cell
lung cancer (NSCLC), pancreatic cancer, and colorectal cancer. Examples of drugs that
make up this class of targeted medications include cetuximab, panitumumab, necitumumab,
erlotinib, gefitinib, osimertinib, and afatinib. One of the most common side effects
of these drugs is skin reactions such as papulopustular (acneiform) rash. This study
is for people with EGFR inhibitor-induced rashes.
View Study Details
Kidney Cancer: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal
Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy (IMmotion010)
Lead Researcher: Elizabeth Guancial
You will be randomly assigned to one of the following treatment groups: atezolizumab
or placebo. Neither you nor your study doctor may choose the group you will be in.
You will have a 50/50 chance of being placed in either group.
View Study Details
Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH
Treatment Trial)
This phase II Pediatric MATCH trial studies how well larotrectinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions
that have
spread to other places in the body and have come back or do not respond to treatment.
Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes
needed for
cell growth.
View Study Details
Leukemia (AML & MDS): Connect® MDS and AML: The Myelodysplastic Syndromes (MDS) and
Acute Myeloid Leukemia (AML) Disease Registry
Lead Researcher: Jason Mendler
This study is observational. An observational disease registry study means that only
information about your disease and medical treatment that your study doctor is already
prescribing as part of your standard medical care is collected. Standard medical care
is the treatment normally given for a certain condition or illness.
You will continue with your standard medical care and continue with any medicines
you are now taking, office visits and laboratory testing according to the normal routine
practices of your treating or study doctor(s). No additional medication, or payment
for medication, is provided as part of this study. There is no investigational drug
involved in this study. There will be no additional study visits, procedures, or
testing required for this study. We will only collect this information as it relates
to the standard medical care you are receiving. If you give your consent to participate
in this study, your study doctor will inform your treating doctor(s), if applicable,
that you are taking part in this study.
View Study Details
Leukemia (AML & MDS): Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine
and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid
Leukemia or High-Risk Myelodysplastic Syndrome
Lead Researcher: Kristen O'Dwyer
If you participate in this study you will randomly be assigned to one of the following
treatment groups; Group A: azacitidine alone, Group B: azacitidine and nivolumab,
or Group C: azacitidine and midostaurin. The cycles for all study groups will repeat
until your disease gets worse or you or your study doctor decide you should stop.
Each cycle is 28 days.
View Study Details
Leukemia (AML): Ivosidenib Expanded Access Program in Relapsed/Refractory AML With
an IDH1 Mutation
Lead Researcher: Jason Mendler
This is an expanded access program. The program is sponsored by the pharmaceutical
company named Agios Pharmaceuticals, Inc. (the "Sponsor"). The purpose of this EAP
is to provide access to ivosidenib to qualifying patients during the period of time
prior to the potential approval and commercial availability of ivosidenib.
View Study Details
Leukemia (AMS or MDS): A Biomarker-Directed Phase 2 Trial of SY-1425 in Patients With
Acute Myeloid Leukemia or Myelodysplastic Syndrome
Lead Researcher: Jane Liesveld
The study includes three different groups. Two of these groups will receive SY-1425
alone. The other group will receive SY-1425 along with another drug called azacitidine.
Your study doctor will discuss the study with you to determine which group you will
be assigned.
View Study Details
Leukemia Treatment: Adding an Antibody to Front-Line Chemotherapy
Lead Researcher: Kristen O'Dwyer
Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different
ways by targeting certain cells. Drugs used in chemotherapy work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy
may work better in treating young adults with B acute lymphoblastic leukemia. This
trial studies the side effects of inotuzumab ozogamicin and how well it works when
given with front-line chemotherapy in treating patients with newly diagnosed B acute
lymphoblastic leukemia.
View Study Details
Leukemia: A program for monitoring minimal residual disease following treatment of
patients with Acute Myeloid Leukemia or High Grade Myelodysplastic Syndrome.
Lead Researcher: Michael Becker
This study is being performed to develop better tests to determine the impact of the
therapy you are receiving for treatment of your AML or MDS and to determine if these
tests can identify those patients who are at a greater risk for having their disease
relapse. Following therapy, the majority of patients with AML and many patients with
MDS will achieve a remission that is defined by the lack of any evidence of the disease
when viewing bone marrow samples under a microscope. Despite the absence of disease
by this method, many patients in remission will still have what is referred to as
Minimal Residual Disease when more sensitive methods are applied. That is, even though
the disease cannot be seen by routine staining under the microscope, more sensitive
tests can detect its presence. The presence of Minimal Residual Disease following
therapy does not guarantee that the patient will experience a relapse. This is likely
a result of the failure of these techniques to examine those cells that are responsible
for disease relapse. Recent data suggests that in the majority of patients with AML
or MDS only a minor population of the malignant cells are capable of maintaining the
disease and are likely responsible for relapse following therapy. This minor population
of cells can be identified by the proteins they have on their surface. This study
tests the ability to identify Minimal Residual Disease following therapy by performing
special assays that specifically target this minor population of malignant cells.
View Study Details
Leukemia: Characterization of the bone marrow microenvironment in patients with myelodysplastic
syndrome (MDS)
Lead Researcher: Michael Becker
This study is being performed to begin to understand the interactions between MDS
tumor cells and the normal bone marrow supporting cells, termed the bone marrow microenvironment.
View Study Details
Leukemia: Combination Chemotherapy With or Without Blinatumomab in Treating Patients
With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (ALL)
Lead Researcher: Kristen O'Dwyer
Studies are being done in ALL and other blood cancers with blinatumomab. It is hoped
that blinatumomab will target your B-cell ALL and destroy these specific cells, but
it has not yet been proven.
View Study Details
Leukemia: Phase I Testing the Addition of Inotuzumab Ozogamicin, to Usual Chemotherapy
in Relapsed and Refractory Acute Leukemia
Lead Researcher: Michael Becker
The purpose of this study is to test the safety of the experimental drug inotuzumab
ozogamicin at different doses to find out what effects, if any, it has on people.
The researchers also want to determine the effects, good and/or bad, of adding inotuzumab
ozogamicin to regular chemotherapy with cyclophosphamide, vincristine and prednisone
(CVP). While researchers hope that adding inotuzumab ozogamicin will be a better
treatment, there is no proof of this.
View Study Details
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements
to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing
Colonopathy)
This is a long-term study in cystic fibrosis patients who are participating in the
Cystic
Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel
disorder
called fibrosing colonopathy (narrowing of the large intestine). Patients will be
followed at
their regular clinical care visits over a 10-year period and approached if they develop
symptoms of fibrosing colonopathy for collection and use of further detailed information.
View Study Details
Lung Cancer (NSCLC): A Dose Escalation Study Of PF-06801591 In Melanoma, Head And
Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma
or Other Solid Tumors
Lead Researcher: Megan Baumgart
There are 2 parts to this study: dose escalation (Part 1) and dose expansion (Part
2). For Part 1, different doses and types of administration of PF-06801591 were tested
and the information gathered was used to determine the optimal dosing regimen for
further evaluation in Part 2. This study is currently open to Part 2; you will receive
the investigational drug, PF06801591 every 28 days.
View Study Details
Lung Cancer (NSCLC): A Study Of Lorlatinib Versus Crizotinib In First Line Treatment
Of Patients With ALK-Positive NSCLC
Lead Researcher: Megan Baumgart
If you participate in this research study, you will be assigned by chance (like flip
of a coin or drawing straws) to receive either lorlatinib alone (Group A) or crizotinib
alone (Group B). You will have a 50% (1 in 2) chance of receiving lorlatinib, and
a 50% (1 in 2) chance of receiving crizotinib. Neither you nor your doctor can choose
the group you will be in.
View Study Details
Lung Cancer (NSCLC): Expanded Access For Lorlatinib For Patients With Non Small Cell
Lung Cancer Carrying an ALK or ROS1 Rearrangement
Lead Researcher: Deborah Mulford
This is an expanded access program. The program is sponsored by the pharmaceutical
company named Pfizer, Inc. (the "Sponsor"). The purpose of this program is to allow
patients with advanced non-small cell lung cancer access to lorlatinib treatment and
to find out the good and bad effects of this drug.
View Study Details
Lung Cancer: "Lung-MAP" S1400 ~ Biomarker-Targeted Second-Line Therapy in Treating
Patients With Recurrent Stage IIIB-IV Squamous Cell Lung Cancer
Lead Researcher: Eric Kim
The purpose of this study screening step is to perform genetic tests on your tumor
sample for certain features that investigational targeted agents used in this study
are specifically designed to work against.
The purpose of the treatment part of this study is to compare the effects, good and
bad, of these investigational agents to the usual approach to treating your type of
cancer. It may be possible that you will not be able to participate in the treatment
part of this study. This could happen if it is unsafe for you to receive the investigational
treatment. You may also choose to not participate in the treatment portion of the
study. Before you decide to get treatment on the study, you will be given information
about the study treatment and you will be asked if you wish to continue on this research
study.
The study has two steps:
• The initial screening step where we will examine your tumor tissue, and
• The sub-study treatment step which will be discussed in a separate consent form.
There will be many sub-studies that are open for patients at a given time. The sub-study
that you will be offered will depend on a combination of the results of the testing
done on your tumor sample, and which sub-studies are available when you are ready
to get treatment on this study. The testing done on you tumor sample is examining
the presence or absence of certain biomarkers. These biomarkers are either changes
in genes or proteins in cancer cells that may be associated with cancer growth.
If your tumor has just one biomarker with a sub-study designed for that biomarker,
you will be assigned to that sub-study. If your tumor has multiple biomarkers with
sub-studies designed for them, you will be assigned to one of the related biomarker
sub-studies randomly (by chance).
Additionally, once you are assigned to a sub-study, a computer will assign you by
chance to one of the treatment groups in the sub-study. This is called “randomization.”
This is done by chance because no one knows if one treatment is better or worse than
the other. In each of the sub-studies an investigational treatment will be compared
to a standard treatment.
View Study Details
Lung Cancer: Afatinib Dimaleate With or Without Cetuximab in Treating Patients With
Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung
Cancer
Lead Researcher: Megan Baumgart
If you are in Group 1, you will receive the study drugs afatinib and cetuximab. The
combination of the two drugs is considered investigational. Once every two weeks
you will receive cetuximab which will be given into a vein. Before receiving cetuximab,
you will receive diphenhydramine hydrochloride (Benadryl) to help prevent a hypersensitivity
reaction. You will also take one afatinib tablet every day. Afatinib is to be taken
by mouth on an empty stomach (at least one hour before eating or two hours after a
meal). Every 28 days is considered a "cycle."
If you are in Group 2, you will receive afatinib alone. You will take one afatinib
tablet every day. Afatinib is to be taken by mouth on an empty stomach (at least
one hour before eating or two hours after a meal). Every 28 days is considered a
"cycle."
View Study Details
Lung Cancer: Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating
Patients With Extensive Stage Small Cell Lung Cancer
Lead Researcher: Megan Baumgart
If you decide to participate in this study you will be assigned to one of the two
treatment groups by chance. This is done by chance because no one knows if one study
group is better or worse than the other. Group 1 will receive the study drug nivolumab
in combination with the usual chemotherapy regimen of platinum (cisplatin or carboplatin)
and etoposide administered by an intravenous (IV) infusion. Group 2 will receive the
usual chemotherapy alone administered by an intravenous (IV) infusion.
View Study Details
Lung Cancer: VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung
Cancer (CLASSICAL-Lung)
Lead Researcher: Megan Baumgart
There are 2 phases in this study. If you are in the dose finding phase of the study,
the dose level of VX15/2503 that you receive is depends on when you enter the study.
The first group of subjects in this study will get a low dose of VX15/2503. If that
dose is well tolerated by those subjects, then the next group of subjects will get
a higher dose of VX15/2503. This will continue until the highest tolerable, safe dose
of VX15/2503 is reached. The dose expansion phase will begin begin after the highest
tolerable dose, or recommended phase 2 dosage (dose to be tested in expansion), has
been identified in the dose finding phase of the trial.
View Study Details
Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes
data in patients with hematological malignancies
Lead Researcher: Walter Burack
This research is being done because we hope that a better understanding of hematologic
malignancies will allow us to develop new and better treatments.
View Study Details
Lymphoma (Diffuse Large B Cell): A Study Evaluating the Efficacy of Axicabtagene Ciloleucel
Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse
Large B Cell Lymphoma (DLBCL) (ZUMA-7)
Lead Researcher: Patrick Reagan
If you decide to participate in this study, you will be randomized or assigned to
one of two study groups based on your previous response to therapy and the International
Prognostic Index score, a tool used to predict the likely course of your disease.
The Experimental Treatment Group will undergo collection of white blood cells by a
process called leukapheresis in order to manufacture your T cells into axi-cel, three
days of conditioning chemotherapy, and a single infusion of axi-cel. If your Study
Doctor believes the current status of your disease is rapidly progressing, you may
receive steroid therapy while axi-cel is being manufactured.
The Standard of Care (SOC) Treatment Group will receive standard of care therapies
including two or three cycles of second-line platinum-based combination chemotherapy
regimens with rituximab; R-ICE (Rituximab, Ifosfamide, Carboplatin, Etoposide), R-DHAP
(Rituximab, Dexamethasone, High-dose Cytarabine, Platinum) R-ESHAP (Rituximab, Etoposide,
Methylprednisolone, Cytarabine, Cisplatin) or R-GDP (Rituximab, Gemcitabine, Dexamethasone,
Platinum), as selected by your Study Doctor. If your cancer responds to the chemotherapy
treatment, you will also receive high dose therapy and ASCT per your Study Doctor.
View Study Details
Lymphoma (DLBCL): A Study Comparing the Efficacy & Safety of Polatuzumab Vedotin w/
Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone vs Rituximab-Cyclophosphamide,
Doxorubicin, Vincristine, & Prednisone in Diffuse Large B-Cell Lymphoma (POLARIX)
Lead Researcher: Patrick Reagan
If you decide to participate in this study you will be randomly assigned by a computer
program to one of the following treatment groups: polatuzumab vedotin and R-CHP with
placebo, or R-CHOP with placebo. Since the difference between the treatment groups
is polatuzumab vedotin in one group and vincristine (O) in the other, both groups
will receive a placebo, which is a substance that looks like either polatuzumab vedotin
or vincristine but contains no active medication. Neither you nor your study doctor
may choose the group that you will be in. You will have an equal chance of being placed
in either group. Neither you nor your study doctor will know which treatment you
receive.
View Study Details
Lymphoma (DLBCL): Impact of CD34+ Cell Dose on Progression-free Survival Following
High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory
Diffuse Large B-cell Lymphoma (DLBCL)
Lead Researcher: Michael Becker
Autologous transplant is the standard treatment for relapsed DLBCL or DLBCL that did
not respond to initial chemotherapy. This is a randomized study, a computer program
will assign subjects to either the experimental or standard arm. Neither you nor your
study doctor will know what group you will be in.
View Study Details
Lymphoma (FL): Obinutuzumab With or Without PI3K-delta Inhibitor TGR-1202, Lenalidomide,
or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade
I-IIIa Follicular Lymphoma
Lead Researcher: Paul Barr
During the study, you will get either obinutuzumab plus TGR-1202, obinutuzumab plus
lenalidomide, or obinutuzumab plus the usual approach treatment for your cancer.
View Study Details
Lymphoma (Follicular Lymphoma (FL)): Pilot Study to Evaluate Circulating Tumor DNA
in Follicular Lymphoma
Lead Researcher: Paul Barr
If you are eligible and agree to participate in this research study the following
will occur:
Stored tumor tissue from a previous biopsy will be collected to look at genomic changes
in your tumor tissue.
Blood collection; about 4 teaspoons of blood will be collected up to 4 times during
your routine clinic visits to look at tumor genetic changes over time.
View Study Details
Lymphoma/Leukemia (CLL/SLL): A Study Comparing BGB-3111 With Bendamustine Plus Rituximab
in Patients With Previously Untreated CLL or SLL
Lead Researcher: Paul Barr
If you decide to participate in this study; as part of the screening tests for the
study, your blood will be tested to determine whether you have CLL/SLL that has a
mutation (a change) in one of the chromosomes called ‘17p deletion’.
If you have CLL/SLL that does not have the 17p deletion, you will be in Cohort 1 and
will be randomly assigned by a computer program to one of the following treatment
groups in Cohort 1: BGB-3111 or B+R. When you are “randomly assigned” it means you
are put into a group by chance, like flipping a coin. Neither you nor your study
doctor may choose the treatment you will take. You will have an equal chance of receiving
either treatment in Cohort 1.
If your CLL/SLL has the 17p deletion, you will be assigned to Cohort 2 and will receive
BGB-3111.
View Study Details
Lymphoma/Leukemia (CLL/SLL): Venetoclax in Combination With Ublituximab and Umbralisib
(TGR-1202) in Patients With Relapsed or Refractory CLL/SLL
Lead Researcher: Paul Barr
If you participate in this study, you will start treatment with 3 cycles (each cycle
is 28 days) of the combination of TG-1101 (ublituximab) and TGR-1202. After completing
those 3 cycles, you will be given 4 cycles of treatment with venetoclax and TGR-1202
at different doses to try to find the dose combination that may work the best. Depending
on how your disease responds to treatment, you may then also receive up to 5 cycles
of extended therapy with TGR-1202 alone.
View Study Details
Lymphoma: A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral eFT508 in
Subjects With Hematological Malignancies
Lead Researcher: Paul Barr
This research study has two parts. Part 1 will test the safety and tolerability of
the study drug at different doses and using different ways of taking the drug (powder
mixed with a liquid diluent [suspension] taken once per day or capsules taken once
or twice per day) to determine the recommended dose. Part 2 will test what effects
the study drug has on the cancer and the safety of the study drug when given at the
recommended dose.
View Study Details
Lymphoma: A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory
Mantle Cell Lymphoma (ZUMA-2)
Lead Researcher: Patrick Reagan
The sponsor is testing an experimental treatment named KTE-C19, which uses the patient’s
own genetically altered blood cells to treat cancer. KTE-C19 is made from blood cells
that are removed from the patient. A virus (retrovirus) is used to introduce a gene
that creates a protein (called a chimeric antigen receptor or CAR) on the surface
of T cells, a type of blood cell that fights infection and eliminates cancer cells.
The hope is that the CAR on the T cells will bind to and kill cells that express CD19,
a molecule that is found on B-cell lymphomas.
View Study Details
Lymphoma: A Safety and Efficacy Study of Nivolumab in Combination With Brentuximab
Vedotin to Treat Non-Hodgkin Lymphomas
Lead Researcher: Paul Barr
The purpose of this study is to test the effectiveness (how well the drug works),
safety, and tolerability of an investigational drug called nivolumab (also known as
BMS-936558) in combination with brentuximab vedotin. Nivolumab is an antibody (a type
of human protein) that is being tested to see if it will allow the body’s immune system
to work against tumor cells.
Brentuximab vedotin is an antibody-drug conjugate (a type of human protein linked
to a study drug). The antibody part of the drug binds to CD30 which often occurs on
diseased cells but rarely on normal tissues.
View Study Details
Lymphoma: Brentuximab vedotin and involved site radiotherapy in newly diagnosed, unfavorable
risk Hodgkin lymphoma.
Lead Researcher: Carla Casulo
Early stage, high risk HL has a chance of coming back after standard treatment. The
best treatment for early stage, high risk HL is chemotherapy followed by radiation.
The chemotherapy is called ABVD and has four drugs approved by the Food and Drug Administration
(FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This is a pilot phase
II study of a new treatment plan for your HL. The treatment consists of a new drug,
brentuximab vedotin (BV), combined with adriamycin, vinblastine, and dacarbazine (AVD)
chemotherapy followed by radiation. The purpose of this study is to find out whether
BV with AVD chemotherapy and radiation is a safe and effective treatment. BV is a
type of drug called an antibody drug conjugate. BV has 2 parts; a part that targets
cancer cells (the antibody) and a cell killing part (the chemotherapy). The antibody
part of BV sticks to a target called CD30. CD30 is an important molecule on HL cancer
cells and some normal cells of the immune system. The cell killing part of BV is a
chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody
part of BV sticks to.
View Study Details
Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation
Therapy in Treating Patients With Newly Diagnosed Ependymoma
This partially randomized phase III trial is studying maintenance chemotherapy to
see how
well it works compared to observation following induction chemotherapy and radiation
therapy
in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy,
such
as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work
in
different ways to stop the growth of tumor cells, either by killing the cells, by
stopping
them from dividing, or by stopping them from spreading. Giving more than one drug
(combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy
x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose
of
radiation directly to the tumor may kill more tumor cells and cause less damage to
normal
tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow
doctors to save the part of the body where the cancer started.
View Study Details
Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating
Patients With Stage IV Non-small Cell Lung Cancer
This randomized phase II/III trial studies how well giving maintenance chemotherapy
with or
without stereotactic body radiation therapy works in treating patients with stage
IV
non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel,
pemetrexed disodium, and gemcitabine work in different ways to stop the growth of
tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading. Stereotactic body radiation therapy is a specialized radiation therapy
that sends
x-rays directly to the tumor using smaller doses over several days and may cause less
damage
to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation
therapy
together may work better than maintenance chemotherapy alone in treating patients
with stage
IV non-small cell lung cancer.
View Study Details
Management of the PDA Trial
Patent ductus arteriosus (PDA) is an extra blood vessel found in babies before birth
and just after birth. In most babies who have an otherwise normal heart, the PDA
will shrink and close on its own in the first few days of life. If it stays open longer,
it may cause extra blood to flow to the lungs. This study estimates the risks and
benefits of active treatment versus expectant management of premature babies with
patent ductus arteriosus.
View Study Details
Measuring Surgical Recovery After Radical Cystectomy
The intent of this study is to establish a registry of post‐surgical outcomes in patients
undergoing radical cystectomy. The goals of this initiative are to obtain a detailed
baseline of multiple
patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various
presenting conditions associated with them, so that future quality improvement interventions
can be evaluated accurately as to their relative contribution to improved outcomes.
View Study Details
Medication Study for Patients with Moderate to Severe Ulcerative Colitis
Lead Researcher: Lawrence Saubermann
This Pfizer study is a Phase 2B trial for patients who have moderate to severe ulcerative
colitis. The medication's being tested in this study are JAK inhibitors labeled as
PF-06651600 and PF-06700841. In order to be eligible for this study participants must
be between the ages of 18 and 70, have active ulcerative colitis for at least four
months prior to entry into this study, and have an inadequate response to one conventional
therapy for ulcerative colitis.
View Study Details
Melanoma: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab
and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage
III-IV BRAFV600 Melanoma
Lead Researcher: Deepak Sahasrabudhe
The BRAF inhibitor component will include two drugs dabrafenib and trametinib that
each have been approved by the FDA for the treatment of this patient population and
have also been approved for use in combination due to superior effects relative to
the single agent treatments. In addition, the study will involve the addition of the
FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy
in the hopes that it might further improve the good effects of the immunotherapy component
of the treatment sequence.
View Study Details
Melanoma: Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAF Mutant
Melanoma That Cannot Be Removed by Surgery
Lead Researcher: Deepak Sahasrabudhe
This study will allow the researchers to know whether a break in treatment is better,
the same, or worse than continuous treatment of dabrafenib and trametinib. To be better,
the break in treatment approach should extend the time before cancer gets worse by
about 4 to 6 months compared to the continuous treatment approach.
View Study Details
Melanoma: Ipilimumab With or Without Nivolumab in Treating Patients With Melanoma
That Is Stage IV or Stage III and Cannot Be Removed by Surgery
Lead Researcher: Deepak Sahasrabudhe
If you decide to participate in this research study, you will be randomly assigned
to one of the treatment groups. This is done by chance, for every patient assigned
to group 1 (ipilimumab alone) the computer will assign 3 patients to group 2 (ipilimumab
and nivolumab). If you are assigned to group 1 (ipilimumab alone), you will receive
the study drug for 12 weeks. If you are assigned to group 2 (ipilimumab and nivolumab)
you will receive both ipilimumab and nivolumab for 12 weeks and then nivolumab alone
for as long as your cancer does not get worse, the side effects are tolerable, and
you agree to stay on study.
View Study Details
Metastatic Tumor Research and Outcomes Network
The registry aims to collect patient information such as patient demographics,
co-morbidities, clinical, diagnostic, and therapeutic data, as well as information
on adverse
events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
View Study Details
Mild and Rapidly Improving Stroke Study
The objective of this study is to determine the 90-day outcomes of mild and rapidly
improving
ischemic stroke.
View Study Details
Milrinone in Congenital Diaphragmatic Hernia
Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia
and
persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory
failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant
to
conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased
pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction.
In patients with CDH, left ventricular dysfunction, either caused by right ventricular
overload or a relative underdevelopment of the left ventricle, is associated with
poor
prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic
contraction and diastolic relaxation respectively) with pulmonary vasodilator properties
and
has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used
during
the management of CDH although no randomized trials have been performed to test its
efficacy.
Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND)
and
22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone.
In the recently published VICI trial, 84% of patients with CDH received a vasoactive
medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis
of
CDH will be randomized to receive milrinone or placebo to establish safety of this
medication
in CDH and test its efficacy in improving oxygenation.
View Study Details
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
Apnea of prematurity (AOP) is a condition in which premature infants stop breathing
for 15 to 20 seconds during sleep. The objective of this study is to evaluate the
effect of continuing treatment with caffeine citrate in the hospital and at home
in moderately preterm infants with resolved apnea of prematurity on days of hospitalization
after randomization.
View Study Details
MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
The purpose of this study is to test whether patients undergoing a breast MRI (magnetic
resonance imaging) before breast surgery will have better results after the surgery.
Breast
tumors are routinely evaluated using mammograms and ultrasound before surgery. This
study
would like to find out if using MRI in addition to mammography before surgery improves
our
ability to evaluate tumors and decide what kind of surgery is best for the patient.
View Study Details
MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
Lead Researcher: Kristin Skinner
The purpose of this study is to test whether patients undergoing a breast MRI (magnetic
resonance imaging) before breast surgery will have better results after the surgery.
Breast tumors are routinely evaluated using mammograms and ultrasound before surgery.
View Study Details
MS PATHS Normative Sub-Study
Lead Researcher: Megan Hyland
The primary objective of this study is to determine the normative range of brain volume
and
brain volume change in healthy control (HC) participants whose age, race, and gender
distribution is approximately matched to the age, race, and gender distribution of
patients
with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is
to use
the results of the primary endpoint to ensure consistency of brain volume measurements
across
MS PATHS centers.
View Study Details
Multiple Cancers: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination
With Immune Therapies in Advanced or Metastatic Malignancies
Lead Researcher: Marcus Noel
This study has 2 phases; depending on when you are enrolled into the study and what
type of cancer you have, you will participate in 1 of the 2 phases.
Phase 1 is the “Dose Escalation” portion of the Study. Certain dose levels of INCAGN01949,
when given together with nivolumab and/or ipilimumab, will be evaluated in small groups
of subjects (also called “cohorts”) with advanced or metastatic cervical cancer, uterine
cancer, stomach cancer, throat cancer, liver cancer, specific types of skin cancer,
a specific subtype of colon cancer, lung cancer, ovarian cancer, head and neck cancer,
kidney cancer, a certain type of breast cancer, and bladder and urinary tract cancer.
Subjects will be observed for a minimum of 28 days before the dose is increased for
the next cohort. Phase 1 subjects will enroll into 1 of 3 different Study Drug Combination
groups. Enrollment in this phase of the Study will continue until the highest dose
of INCAGN01949 that is safe and tolerated by most subjects is found.Some subjects
will be enrolled into safety expansion cohorts within Phase 1. These subjects will
receive the same combinations and doses given in the dose escalation part of the study,
however the administration of nivolumab and/or ipilimumab will begin after 2 cycles
of INCAGN01949 are given.
Phase 2 is the “Dose Expansion” portion of the Study. The dose of INCAGN01949 determined
to be safe during the Phase 1 (Dose Escalation) portion of the Study will be given
together with nivolumab and/or ipilimumab to subjects with kidney cancer or bladder
and urinary tract cancer in 1 of 6 different Study Drug Combination groups. The dose
of INCAGN01949 you receive in this Study will depend on the dose level being tested
at the time you are enrolled. The doses of nivolumab and ipilimumab administered to
you in this Study will not change.
View Study Details
Multiple Cancers: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Lead Researcher: Paul Barr
If you participate in this study you will receive the study drugs ipilimumab and
nivolumab. You will receive both study drugs through a vein on the first day of each
cycle (or every 6 weeks), and you will receive nivolumab through a vein every 2 weeks.
You will continue to receive study drugs until your disease gets worse or you experience
bad side effects from the study drugs or your study doctor decides that you are not
benefiting from the study drugs.
View Study Details
Multiple Cancers: Targeted Therapy Directed by Genetic Testing in Treating Patients
With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening
Trial)
Lead Researcher: Marcus Noel
If you decide to participate in this study, your tumor cells will be tested to find
out if they have a gene change or mutation targeted by one or more of the drugs used
in this study. If you have a gene change or mutation that matches a substudy, you
will be asked if you want to participate in a specific substudy.
View Study Details
Multiple Myeloma
Lead Researcher: Brea Lipe
The purpose of this study is to collect clinical data along with bone marrow aspirate
samples to see if there is a way to determine which patients are more or less likely
to experience disease progression. This study will involve identifying different
markers on the surfaces of the plasma cells and will look at protein expression.
We will then correlate those findings with data from your medical records over time.
If you decide to take part in this study, you will be asked to allow additional bone
marrow aspirate and blood samples to be collected for research at several time points.
These additional samples will be collected during routine testing time points as required
for your routine care. We will also collect information about your disease and treatment
from your medical record.
View Study Details
Multiple Myeloma: A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
Lead Researcher: Brea Lipe
If you decide to participate in this study you will receive denosumab every 4 weeks
for a total of 12 cycles.
View Study Details
Myelodysplastic Syndromes: A Safety and Efficacy Study of Pracinostat and Azacitidine
in Patients With High Risk Myelodysplastic Syndromes
Lead Researcher: Jason Mendler
In this research study, you will take either pracinostat or placebo 3 times a week
for 3 weeks in a row followed by 1 week of rest. All subjects will receive azacitidine.
View Study Details
Myocardial Ischemia and Transfusion
The purpose of this study is to compare two red blood cell transfusion strategies
(liberal
and restrictive) for patients who have had an acute myocardial infarction and are
anemic.
View Study Details
Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry
Lead Researcher: Al-rabi Tawil
Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited
disorders characterized by progressive muscle weakness and loss of muscle tissue.
The purpose of this registry is to connect people with DM or FSHD with researchers
studying these diseases. The registry will offer individuals with DM and FSHD an opportunity
to participate in research that focuses of their diseases. The registry will also
help scientists to accomplish research on DM and FSHD and to distribute their findings
to patients and care providers.
View Study Details
Nasal and Paranasal Sinus Cancer: a study comparing chemotherapy before surgery &
radiation therapy Vs. surgery & radiation therapy alone
Lead Researcher: Ronald Maggiore
Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin work in
different ways to stop the growth of tumor cells, either by killing the cells, by
stopping them from dividing, or by stopping them from spreading. Radiation therapy
uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy
before surgery and radiation therapy may make the tumor smaller and reduce the amount
of normal tissue that needs to be removed and treated with radiation. This trial studies
how well chemotherapy before surgery and radiation therapy works compared to surgery
and radiation therapy alone in treating patients with nasal and paranasal sinus cancer.
View Study Details
Neuropsychological and Behavioral Testing in Younger Patients With Cancer
This research trial studies neuropsychological (learning, remembering or thinking)
and
behavioral testing in younger patients with cancer. Collecting information over time
from a
series of tests may help doctors develop effective tests to measure neuropsychological
and
behavioral function of patients with cancer.
View Study Details
NIR Fluorescence Imaging of Lymphatic Transport Using ICG
Lead Researcher: Christopher Ritchlin
Healthy volunteers and patients with Rheumatoid Arthritis (RA) in the developmental
arm will have a minimum of two study visits to determine the optimal conditions for
visualizing lymphatic transport in the upper extremities. Concentrations of 0.1 mg/ml
of Indocyanine Green (ICG) will be injected intradermally into the web spaces of the
hands in both upper extremities. Multispectral video and still images will be recorded
using the MultiSpectral Imaging System (MSImager). An ultrasound of the upper extremities
may be performed after the ICG fluorescence is observed. The exam will help identify
the location of the lymphatic vessels and nodes in the areas fluoresced.
View Study Details
Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small
Cell Lung Cancer (An ALCHEMIST Treatment Trial)
This phase III ALCHEMIST trial studies how well nivolumab after surgery and chemotherapy
work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal
antibodies, such as nivolumab, may stimulate the immune system in different ways and
kill tumor cells remaining after surgery and standard of care chemotherapy.
View Study Details
Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II
Meningioma That Has Been Completely Removed by Surgery
This randomized phase III trial studies how well radiation therapy works compared
with
observation in treating patients with newly diagnosed grade II meningioma that has
been
completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor
cells
and shrink tumors.
View Study Details
Ocaliva with Liver Cirrhosis
Lead Researcher: Jonathan Huang
Study participation is a minimum of 1 year, with up to 2 full years of participation
possible. Subjects will be randomized to take either 10mg or 25mg of Ocaliva or placebo
pill once daily. Subjects must come into the clinic for study related procedures a
minimum of 10 times. A liver biopsy is required.
View Study Details
OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
Lead Researcher: Li-Xing Man
This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter
Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents
with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The
total planned number of subjects is approximately 120 adolescents (12-17 years of
age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1
ratio (OPN-375 186 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled
to obtain 10 completers.
View Study Details
Ovarian Cancer: A Study of Niraparib Maintenance Treatment in Patients With Advanced
Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Lead Researcher: Richard Moore
If you agree to be in this study, you will either take the Study Drug, niraparib,
capsules or placebo capsules by mouth once daily. You have a 2 in 3 chance of receiving
study drug. Neither you or your study doctor will know if you receive niraparib or
placebo.
View Study Details
Ovarian Cancer: Efficacy and Safety Study of Cediranib in Combination With Olaparib
in Patients With Recurrent Platinum-Resistant Ovarian Cancer (CONCERTO)
Lead Researcher: Richard Moore
The purpose of the study is to see if the combination of two drugs, cediranib and
olaparib, is effective and tolerable in patients with ovarian cancer who have received
at least 3 prior chemotherapy treatments, including treatment that included either
carboplatin or cisplatin, and their disease came back within 6 months of the last
dose of chemotherapy that included either cisplatin or carboplatin.
View Study Details
Ovarian Cancer: Evaluation of a blood test that could help determine if a pelvic mass
is cancerous or non-cancerous
Lead Researcher: Richard Moore
The purpose of this study is to validate and refine a technology that can help physicians
determine whether an abnormal pelvic mass in women is benign (non-cancerous) or malignant
(cancerous) using a blood test. The specific technology is called ParsortixTM PC1
system, a semi-automated system capable of capturing and harvesting rare cells for
subsequent analysis from blood based on the size and deformability (i.e.compressibility)
of the cells.
View Study Details
Ovarian Cancer: Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or
Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary
Peritoneal Cancer
Lead Researcher: Richard Moore
This study has 3 study groups, a computer will assign you to a study group by chance.
There is an equal chance of receiving each treatment. This is done by chance, because
no one knows if one study group is better or worse than the others. Group 1 will get
an experimental chemotherapy treatment (liposomal doxorubicin and atezolizumab), group
2 will get an experimental chemotherapy treatment (liposomal doxorubicin and bevacizumab
plus atezolizumab), and group 3 will get a usual chemotherapy treatment for this type
of cancer (liposomal doxorubicin and bevacizumab). The liposomal doxorubicin will
be given into your vein over approximately 60 minutes. The bevacizumab will be given
into your vein over approximately 90 minutes initially, then faster at later visits
if administration goes smoothly at the slower rates. The atezolizumab will be given
into your vein over approximately 60 minutes initially, then faster at later visits
if administration goes smoothly at the slower rates. Treatment will be given on days
1 and 15 of each 28-day period. This period of time is called a cycle, which is a
regular schedule of treatment with periods of rest in between.
View Study Details
Ovarian Cancer: Phase 2, A Study of Niraparib Combined With Bevacizumab Maintenance
Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line
Platinum-Based Chemotherapy
Lead Researcher: Richard Moore
It is not known how long your participation the study will last. You may receive Niraparib
for up to 3 years and Bevacizumab for up to 15 months. The number of months that you
receive bevacizumab on the study depends on how many months of bevacizumab you received
with chemotherapy before this study.
View Study Details
Ovarian Cancer: Tesaro-FIRST
Lead Researcher: Richard Moore
The purpose of this study is to compare the progression-free survival of patients
with Stage III or IV non-mucinous epithelial ovarian cancer treated with platinum-based
therapy, TSR-042, and niraparib to standard-of-care (SOC) platinum-based therapy.
View Study Details
Ovarian Cancer: Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer
in Low Risk Women
Lead Researcher: Richard Moore
You will have blood drawn for the CA-125 testing and other tumor markers, depending
on your CA-125 level, you will return and have blood drawn in 1 year or in 3 months
or in 6 weeks plus a transvaginal ultrasound.
View Study Details
Ovarian Cancer: Utilizing Human Ovarian, Fallopian and Primary Peritoneal Cancer Patient
Tissue to Identify Novel Therapies
Lead Researcher: Richard Moore
If you decide to take part in this study, you will be asked to donate tissue and ascites
(left over after the surgery), blood and clinical data. Our study team member will
first review your medical records to obtain information on your health status and
history. Then, when you go in for surgery, on the day of surgery less than 4 tablespoons
of blood and tissue samples and ascites fluid will be collected. You will be followed
for information about your health status and treatment for up to 10 years after your
surgery.
View Study Details
Ovarian Ultrasound for Healthy Women and Women with Polycystic Ovary Syndrome
Lead Researcher: Kathleen Hoeger
This study aims to characterize the affect of age and weight on the size and shape
of ovaries. We will compare ovary size and shape in women of varying ages and body
sizes. You are eligible if you are female, age 18-45. We plan to recruit up to 120
women with regular menstrual cycles and up to 120 women with histories of Polycystic
Ovary Syndrome. This study is being conducted in collaboration with Dr. Lujan’s lab
at Cornell University.
View Study Details
Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced
Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations
in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well palbociclib works in treating
patients
with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with
activating
alterations (mutations) in cell cycle genes that have spread to other places in the
body and
have come back or do not respond to treatment. Palbociclib may stop the growth of
cancer
cells by blocking some of the enzymes needed for cell growth.
View Study Details
Pancreatic Cancer: A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in
Adult Patients With Metastatic Pancreatic Adenocarcinoma (CanStem111P)
Lead Researcher: Marcus Noel
There will be two study groups: Group 1 (EXPERIMENTAL TREATMENT): Nab-Paclitaxel with
Gemcitabine plus BBI-608 and Group 2: (NON-EXPERIMENTAL TREATMENT): Nab-Paclitaxel
with Gemcitabine. Researchers are hoping to learn if patients will have a longer cancer
free survival when receiving a standard chemotherapy regimen with the study drug,
BBI-608 versus standard chemotherapy regimen alone.
View Study Details
Pancreatic Cancer: PEGylated Recombinant Human Hyaluronidase in Combo With Nab-Paclitaxel
+ Gemcitabine VS. Placebo + Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High
Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Lead Researcher: Marcus Noel
PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan
(HA) produced by some tumors. Currently PEGPH20 is experimental and is being tested
in patients with pancreatic and lung cancers.
View Study Details
Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
The emergency department (ED) is a common source of acute illness care for older adults.
Many
older adults who are discharged home from the ED return within 30 days due to numerous
challenges faced during the ED-to-home transition. Unless programs to improve the
ED-to-home
transition are identified, the health and financial costs will only increase as the
older
adult population doubles by 2040. This study will apply Coleman's Care Transitions
Intervention to the ED-to-home transition by adapting the program to account for the
unique
aspects of the ED setting. The research will evaluate the process, ED use, and cost
outcomes
of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion,
this study will provide empiric evidence regarding this innovative approach to help
the
rapidly growing older adult population remain healthy and independent after an ED
visit.
View Study Details
Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory
Hodgkin Lymphoma
Lead Researcher: Carla Casulo
The purpose of this research study is to evaluate a new drug Pembrolizumab in combination
with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen
is called "ICE" and includes three drugs: ifosfamide, carboplatin, and etoposide.
Pembrolizumab is currently Food and Drug Administration (FDA) approved for the treatment
of some patients with melanoma, lung cancer and head and neck cancer, but has not
yet been approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma. The 'ICE'
regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory
Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab
for this disease. For patients who have a relapse of their Hodgkin's lymphoma, retreatment
with chemotherapy followed by a stem cell transplant is recommended. We know that
obtaining a complete remission (not able to detect any disease on scans) is very important
prior to proceeding to the stem cell transplant. Patients with negative scans have
a lower chance of the disease coming back and a higher chance of achieving a long-term
cure.
View Study Details
Pevonedistat and Azacitidine in MDS or MDS/MPN Patients
Lead Researcher: Jason Mendler
The purpose of this study is to compare survival of patients treated with a combination
of pevonedistat and azacitidine after failure of DNA methyltransferase inhibitors
to historical survival for patients with relapsed/refractory myelodysplastic syndrome
or myelodysplastic/ myeloproliferative overlap syndromes who are ineligible for hematopoietic
stem cell transplant.
View Study Details
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
To evaluate the safety and tolerability of BIIB092 in participants with mild cognitive
impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. To evaluate the
efficacy of
multiple doses of BIIB092 in slowing cognitive and functional impairment in participants
with
MCI due to AD or with mild AD. To evaluate the immunogenicity of BIIB092 after multiple
doses
in participants with MCI due to AD or with mild AD.
View Study Details
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC PB1046
in Subjects With Symptomatic PAH
Pulmonary arterial hypertension (PAH) is one form of a broader condition known as
pulmonary hypertension, which means high blood pressure in the lungs.
This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess
the safety, tolerability, and efficacy of PB1046 in patients with pulmonary arterial
hypertension.
View Study Details
Phase 3 Alogliptin Pediatric Study
This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD)
compared
to placebo when administered as monotherapy, or when added onto a background of metformin
alone, insulin alone, or a combination of metformin and insulin in pediatric participants
10
to 17 years of age with type 2 diabetes mellitus (T2DM).
View Study Details
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary
Biliary Cholangitis
Primary Biliary Cholangitis (PBC) formerly known as primary biliary cirrhosis is a
serious, life-threatening, bile acid related liver disease of unknown cause. Without
treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring
liver transplantation or resulting in death. The investigational drug, Obeticholic
Acid (OCA) helps prevent liver damage and improves liver function. The study will
assess the effect of OCA compared to placebo, combined with stable standard care,
on clinical outcomes in PBC patients.
View Study Details
Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in
Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
Lead Researcher: Yuhchyau Chen
The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane)
and
carboplatin with concurrent radiation in local-regionally advanced lung cancer. There
are no
published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators
will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane)
at
50mg/m2, and then will begin enrolling patients into the phase II component using
either
Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation
or
paclitaxel with with carboplatin concurrent with daily radiation.
View Study Details
PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced
Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR
Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well PI3K/mTOR inhibitor LY3023414
works in
treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders
with TSC
or PI3K/MTOR mutations that have spread to other places in the body and have come
back or do
not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer
cells
by blocking some of the enzymes needed for cell growth.
View Study Details
PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
The objective of this study is to evaluate the safety of long-term treatment with
Kuvan.
View Study Details
Preemie Hypothermia for Neonatal Encephalopathy
Lead Researcher: Carl D'Angio
Encephalopathy is a general term that means brain disease, damage, or malfunction.
This study is a randomized, controlled trial to assess safety and effectiveness of
whole body
hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present
at
<6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study
will
enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly
assign them to either receive hypothermia or participate in a non-cooled control group.
View Study Details
Project LITE: Improving Photographs of Bruises
Lead Researcher: Catherine Cerulli
Project LITE in the Department of Psychiatry, in collaboration with the Institute
of Optics Laboratory, has the goal to reduce differences in the quality of bruising
documentation regardless of skin color.
We are looking for people with medium and dark skin tones to test how different light
sources affect photographing bruises. You must be 18 years or older, be a person of
color and have experienced an injury with pain in the past seven days.
The initial appointment will take about 45 mins and you will take a 5-10 minute baseline
survey that will gather information on your age, race, ethnicity, and other demographics.
The survey will also ask about your level of pain and if it disrupts any aspects of
your life. Pictures of your injury will be taken using three different lights and
you will receive copies of the photographs.
You will need to return in 7 days for a 25 min follow up.
You will receive a $25 Wegmans gift card at both the initial and follow-up appointments.
View Study Details
Project: Every Child for Younger Patients With Cancer
This research trial studies the Project: Every Child for younger patients with cancer.
Gathering health information over time from younger patients with cancer may help
doctors
find better methods of treatment and on-going care.
View Study Details
Prostate cancer: A laboratory study to isolate and manipulate circulating tumor cells
in prostate cancer.
Lead Researcher: Deepak Sahasrabudhe
If you decide to participate in this study, your blood will be drawn periodically
before, during and after therapy. You will be asked to provide ¬¬¬¬1.5 teaspoons of
blood at a time. Blood samples will be collected before start of treatment and then
approximately every one to three weeks for up to 12 months.
View Study Details
Prostate Cancer: A Study of Rucaparib in Patients With Metastatic Castration-resistant
Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)
Lead Researcher: Elizabeth Guancial
This research study is divided into three phases: Screening Phase is performed to
find out if you are eligible for the study. If you qualify, you will be enrolled into
the study and begin treatment. Treatment Phase (continuous dosing with rucaparib)
Follow-up Phase: Follow Up visit (28 days after your last dose of rucaparib) and long
term follow-up approximately every 12 weeks
View Study Details
Prostate Cancer: A Study of Rucaparib Verses Physician's Choice of Therapy in Patients
With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination
Gene Deficiency (TRITON3)
Lead Researcher: Elizabeth Guancial
If you participate in this study, you will be assigned at random to receive treatment
with either an experimental drug (called rucaparib) or one of the following comparator
treatments: abiraterone acetate, enzalutamide, or docetaxel. If you are assigned to
receive comparator treatment, your study doctor will help determine which one of the
three therapy options is most appropriate for you. Approximately two thirds of the
patients will be assigned to receive treatment with rucaparib and one-third will be
assigned to receive comparator treatment.
View Study Details
Prostate Cancer: Cisplatin in Prostate Cancer
Lead Researcher: Deepak Sahasrabudhe
If you choose to participate in this study, you will receive cisplatin once per week
for 6 weeks and you will continue to receive leuprolide and enzalutamide. You will
also have blood samples collected at enrollment, 3 weeks, 5 weeks, and conclusion
of treatment for research purposes.
View Study Details
Prostate Cancer: ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration
Sensitive Prostate Cancer (ARASENS)
Lead Researcher: Elizabeth Guancial
You will be randomly assigned to a treatment group, Darolutamide (ODM-201) or placebo.
You will have a 1:1 chance of receiving Darolutamide (ODM-201) and a 1:1 chance of
receiving placebo.
View Study Details
Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung
Cancer Receiving Cisplatin and Etoposide
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth
of
tumor cells, either by killing the cells or by stopping them from dividing. It is
not yet
known which radiation therapy regimen is more effective when given together with chemotherapy
in treating patients with limited-stage small cell lung cancer. This randomized phase
III
trial is comparing different chest radiation therapy regimens to see how well they
work in
treating patients with limited-stage small cell lung cancer.
View Study Details
Rare Diseases Clinical Research Network: Neurophysiological Correlates
A biomarker, or biological marker is a measurable indicator of some biological state
or condition. The overall purpose of this project is to advance understanding of the
neurophysiological
features of Rett syndrome (RTT), MECP2 Duplication (MECP2 Dup) and RTT-related disorders
(CDKL5, FOXG1) to gain insight into disease pathogenesis, with an emphasis on identifying
biomarkers of disease evolution and severity. This specific study is intertwined to
the core
study Natural History of Rett Syndrome and Related Disorders (RTT5211), which characterizes
range of clinical involvement and genotype-phenotype correlations and will provide
phenotypical data for determining the clinical relevance of the neurophysiologic parameters;
study subjects here are co- and primarily enrolled in RTT5211. The proposed studies
will
serve as basis of future translational investigations, including further refinement
of
biomarkers, development of outcome measures, and clinical trials per se.
View Study Details
Rectal Cancer: Phase II/III study of FOLFOX chemotherapy with or without radiation
treatment before surgery for locally advanced rectal cancer. (N1048)
Lead Researcher: Mohamedtaki Tejani
The standard treatment for locally advanced rectal cancer involves chemotherapy and
radiation, known as 5FUCMT, (the chemotherapy drugs, 5-fluorouracil/capecitabine and
radiation therapy) prior to surgery. This results in high rates of disease control
with significant side effects.
The purpose of this study is to compare the effects of the standard treatment of chemotherapy
and radiation to chemotherapy alone. The aim of this study is to determine if we
can reduce the side effects while still controlling the disease. The chemotherapy
alone is the combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU),
oxaliplatin and leucovorin). Depending on the response to FOLFOX you may also receive
the standard treatment 5FUCMT. The drugs used in this study are all FDA (Food and
Drug Administration) approved for the treatment of colorectal cancer. The use of FOLFOX
chemotherapy alone in place of 5FUCMT is experimental. In case FOLFOX chemotherapy
alone does not work, you will receive standard treatment which is 5FUCMT followed
by surgery.
View Study Details
Rectal Cancer: Trial Evaluating 3-year Disease Free Survival in Patients With Locally
Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation
Chemotherapy and Total Mesorectal Excision or Non-operative Management
Lead Researcher: Mohamedtaki Tejani
Patients with rectal cancer are given chemotherapy and radiation therapy, and then
they have surgery to remove the rectum. Chemotherapy and radiation therapy are given
at the same time. This is called chemoradiation. Sometimes after surgery, patients
will have extra chemotherapy without radiation. The extra chemotherapy is given to
help make sure the tumor does not come back and to try and cure patients of their
cancer.
The purpose of this study is to increase the number of patients cured from their rectal
cancer by giving the extra chemotherapy before surgery instead of after surgery. We
also want to find out what effects, good and/or bad, having chemotherapy before surgery
has on you and your rectal cancer. We believe that it will be better for you to have
chemotherapy before surgery, but we are not sure if it is better to give the chemotherapy
before or after the chemoradiation.
Another important purpose of this study is to try and avoid surgery in patients with
rectal tumors that have disappeared in response to the chemoradiation and the chemotherapy
given before surgery. We believe that having additional chemotherapy before surgery
may improve the chances that your tumor will disappear and we will be able to save
your rectum.
View Study Details
Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients
With Newly Diagnosed WNT-Driven Medulloblastoma
This phase II trial studies how well reduced doses of radiation therapy to the brain
and
spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed
type of
brain tumor called WNT/Wingless (WNT)-driven medulloblastoma. Recent studies using
chemotherapy and radiation therapy have been shown to be effective in treating patients
with
WNT-driven medulloblastoma. However, there is a concern about the late side effects
of
treatment, such as learning difficulties, lower amounts of hormones, or other problems
in
performing daily activities. Radiotherapy uses high-energy radiation from x-rays to
kill
cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine
sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth
of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill
tumor
cells and may also reduce the late side effects of treatment.
View Study Details
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients
With Non-high Risk Neuroblastoma
This phase III trial studies how well response and biology-based risk factor-guided
therapy
works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor
may
not need treatment until it progresses. In this case, observation may be sufficient.
Measuring biomarkers in tumor cells may help plan when effective treatment is necessary
and
what the best treatment is. Response and biology-based risk factor-guided therapy
may be
effective in treating patients with non-high risk neuroblastoma and may help to avoid
some of
the risks and side effects related to standard treatment.
View Study Details
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or
Myelodysplastic Syndrome in Younger Patients With Down Syndrome
This phase III trial studies response-based chemotherapy in treating newly diagnosed
acute
myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome.
Drugs
used in chemotherapy work in different ways to stop the growth of cancer cells, either
by
killing the cells, by stopping them from dividing, or by stopping them from spreading.
Response-based chemotherapy separates patients into different risk groups and treats
them
according to how they respond to the first course of treatment (Induction I). Response-based
treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome
in
younger patients with Down syndrome while reducing the side effects.
View Study Details
S-CitAD - Escitalopram for Agitation in Alzheimer's Disease
Lead Researcher: Anton Porsteinsson
Individuals with a diagnosis of Alzheimer's disease and clinically significant agitation/aggression
as assessed by the Neuropsychiatric Inventory (NPI), and not residing in a skilled
nursing or long-term acute care facility may be eligible to participate. Enrolled
participants will receive 3 weeks of psychosocial intervention (counseling). Those
responding to counseling will be monitored on usual care. Those not responding to
3 weeks of counseling will randomly be assigned to receive daily escitalopram or placebo
(a pill with no active ingredients) while continuing to receive counseling. These
2 groups will be compared to the group responding to counseling alone.
View Study Details
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
Lead Researcher: David Weber
Chlorthalidone is a prescription drug used to treat high blood pressure (hypertension).
This open-label study will determine if chlorthalidone is safe and effective for the
use of reducing the amount of calcium in urine over 4 weeks in patients with type
1 diabetes.
View Study Details
Safety and efficacy of obeticholic acid in patients with compensated NASH
Lead Researcher: Jonathan Huang
This study will last 2 years and 3 months with the participant visiting the clinic
22 times. This consists of a 1 year double blind period and an optional 1 year open
label period. After the screening period, participants will be randomized into groups
of Placebo medication, 10 mg of OCA, or 10-25 mg of OCA. A liver biopsy is required
for this study at the screening visit if one has not been completed within 12 months
of day 1. This study will also include questionnaires, an EKG of your heart, fasting
blood work, vital signs, and physical examinations. All study medication and protocol
required procedures are covered by the clinical trial sponsor.
View Study Details
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity
Disorder (ADHD)
The purpose of this study is to determine if an investigational treatment is effective
in
improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years
old
diagnosed with ADHD.
View Study Details
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease
(AD)
This randomized, double-blind, placebo-controlled, parallel group study will evaluate
the
efficacy and safety of gantenerumab versus placebo in participants with early (prodromal
to
mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible
participants will be randomized 1:1 to receive either subcutaneous (SC) injection
of
gantenerumab or placebo. The primary efficacy assessment will be performed at the
end of the
double blind period at week 104. Participants will then be offered to enter into an
open-label extension (OLE). Participants not willing to go to the OLE will participate
in a
long term follow-up period for up to 50 weeks after the last gantenerumab dose.
View Study Details
Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated
Urinary Syndromes (FOCUS)
This is a Phase 4, multi-center, open-label, randomized pragmatic superiority clinical
trial
comparing two strategies for initial or step-down oral therapy for complicated urinary
tract
infections (cUTI) after 0-48 hours of parenteral antibiotic therapy. The trial will
evaluate
the success and safety of a strategy of initial or step-down fosfomycin, administered
at a
dose of 3 g once daily, vs. a strategy of initial or step-down levofloxacin administered
at a
dose of 750 mg once daily. Investigator-directed adjustment to another adequate oral
therapy
is allowed 1) if the causative pathogen is not susceptible in vitro to quinolone initial
or
step-down therapy in a subject randomized to the levofloxacin strategy, OR 2) if the
subject
develops a significant related AE (either grade 3 or at the investigator's discretion)
to the
initial or step-down oral therapy. The duration of oral therapy (initial +
investigator-directed adjustment if indicated) in each strategy is 5-7 days of any
per
protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy
depends
on creatinine clearance (CrCl). The trial will enroll approximately 536 patients that
are
either male or female aged 18 or older with cUTI from outpatient and inpatient settings.
The
study will take place over 25 months in approximately 12 to 15 US sites. The primary
objective is to compare Strategy 1 and Strategy 2 in terms of treatment success rates
at Test
of Cure (TOC).
View Study Details
Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive
Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug delivery
system, in combination with nivolumab, is safe and tolerable in patients with muscle-invasive
bladder cancer (MIBC) who are scheduled for radical cystectomy (RC).
View Study Details
Safety of Sildenafil in Premature Infants
Bronchopulmonary dysplasia (BPD) is a form of chronic lung disease that affects newborns
(mostly premature) and infants. It results from damage to the lungs caused by mechanical
ventilation (respirator) and long-term use of oxygen. Most infants recover from BPD,
but some may have long-term breathing difficulty. This study will look at the safety
of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine
preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding Source
- FDA OOPD.
View Study Details
Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF versus
Placebo and G-CSF for patients with multiple myeloma
Lead Researcher: Jane Liesveld
The first part of this study will determine what is the best dose for the drug, BL-8040.
The second part of the study will determine if the drug works well at treating patients
with multiple myeloma.
View Study Details
Sarcoma: Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally
Advanced or Metastatic Sarcoma
Lead Researcher: Deepak Sahasrabudhe
You will receive the MLN0128 for as long as the drug is preventing your cancer from
growing and the side effects are reasonable. After you finish taking MLN0128, your
doctor will continue to watch you for side effects and follow your condition for at
least 30 days. Your doctor will continue to watch you for up to 2 years after you
begin treatment.
View Study Details
Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations
(A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well selumetinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway
activation mutations that have spread to other places in the body and have come back
or do
not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking
some of
the enzymes needed for cell growth.
View Study Details
Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive
Her2 Negative Metastatic Breast Cancer
Lead Researcher: Alissa Huston
This randomized research trial studies how well serum tumor marker directed disease
monitoring works in monitoring patients with hormone receptor positive Her2 negative
breast cancer that has spread to other places in the body. Using markers to prompt
when scans should be ordered may be as good as the usual approach to monitoring disease.
View Study Details
Skin Cancer: Safety and Efficacy of Pembrolizumab (trade name Keytruda) Compared to
Placebo
Lead Researcher: Deepak Sahasrabudhe
Pembrolizumab is an antibody that blocks a protective mechanism of cancer cells and
thereby allows the immune system to destroy them. This study will evaluate pembrolizumab
compared to placebo in participants after the surgical removal of stage II melanoma.
Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind
design for up to 17 cycles. Part 2 is an open-label design for participants who receive
placebo in Part 1 or who stop treatment after receiving 17 cycles of pembrolizumab
in Part 1. They may be eligible to receive up to 35 additional cycles of pembrolizumab
in Part 2.
View Study Details
Skin Cancer: Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Lead Researcher: Sherrif Ibrahim
REGN2810 is a type of drug called a monoclonal antibody. Antibodies are proteins
that are naturally found in your blood stream that fight infections. A monoclonal
antibody is a special kind of antibody that is created in a laboratory. It is a medication
that binds to specific proteins in the body that may be involved in your cancer.
This study is being done to test if REGN2810 can reduce the size of your tumor by
helping the immune system destroy the tumor. The study is also being done to test
the safety of REGN2810 in CSCC patients.
View Study Details
Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating
Patients With Liver Cancer
This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation
therapy to see how well they work compared to sorafenib tosylate alone in treating
patients
with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking
some of
the enzymes needed for cell growth. Stereotactic body radiation therapy may be able
to send
the radiation dose directly to the tumor and cause less damage to normal tissue. Giving
sorafenib tosylate together with stereotactic body radiation therapy may kill more
tumor
cells.
View Study Details
Sound Processing Changes in Babies With Opioid Exposure
Lead Researcher: Perihan Ulema
The purpose of this study is to identify problems with interpreting sounds in babies
that have been exposed to opioids prior to birth. Being able to identify these issues
in infancy may allow us to find children who may have problems with language learning
later in life so that we can try to minimize these.
View Study Details
Squamous Cell Carcinoma of the Head and Neck Cancer: PD 0332991 and Cetuximab in Patients
With Incurable SCCHN
Lead Researcher: Ronald Maggiore
If you participate in this study you will be taking palbociclib and cetuximab as treatment
for your cancer. Palbociclib is taken by mouth once a day and cetuximab is given intravenously
weekly.
View Study Details
Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery
in Treating Patients With Limited Metastatic Breast Cancer
Stereotactic radiosurgery (SRS) is a non-surgical radiation therapy used to treat
functional abnormalities and small tumors of the brain. It can deliver precisely-targeted
radiation in fewer high-dose treatments than traditional therapy, which can help preserve
healthy tissue. This randomized phase II/III trial studies how well standard of care
therapy with
stereotactic radiosurgery and/or surgery works and compares it to standard of care
therapy
alone in treating patients with breast cancer that has spread to one or two locations
in the
body (limited metastatic) that are previously untreated. Standard of care therapy
comprising
chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread
of
tumor cells. Radiation therapy and/or surgery is usually only given with standard
of care
therapy to relieve pain; however, in patients with limited metastatic breast cancer,
stereotactic radiosurgery, also known as stereotactic body radiation therapy, may
be able to
send x-rays directly to the tumor and cause less damage to normal tissue and surgery
may be
able to effectively remove the metastatic tumor cells. It is not yet known whether
standard
of care therapy is more effective with stereotactic radiosurgery and/or surgery in
treating
limited metastatic breast cancer.
View Study Details
Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable
Nasal Dressing
Lead Researcher: Paul Allen
The purpose of this study is to compare how two different post-surgical treatments
that both
deliver steroids to the frontal sinus opening affect your healing after frontal sinus
surgery.
View Study Details
Study of a new cancer sensitivity test (CANscriptTM) that could help inform physicians
in selecting treatments
Lead Researcher: Richard Moore
The purpose of this study is to trial the CANscript™ sensitivity test, which is a
new and different test developed to indicate the sensitivity of different cancer types
to physician-selected therapies (both drugs and/or drug combinations). CANscript™
tests how a patient's specific tumor reacts to the therapies being considered by the
treating physician. CANscript™ test results have been shown to closely correspond
with actual clinical results, providing physicians with information that may help
him/her develop a more personalized cancer treatment and care plan based on the patient's
specific condition. The researchers want to see if CANscript™ test results are helpful
in selecting the treatments prescribed and provided. There will be about 800 people
taking part in this study, across 5 different tumor types. The study is designed to
assess the decision impact of the CANscript™ test results in informing physicians
in therapy selection.
View Study Details
Study of Arimoclomol in Inclusion Body Myositis (IBM)
Lead Researcher: Elizabeth Luebbe
Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and
efficacy
of the study drug, Arimoclomol in IBM patients.
View Study Details
Study of Berkeley Life Nitric Oxide on Platelets
Lead Researcher: Scott Cameron
Nitric Oxide has several protective heart benefits. But why it's protective is not
known. We will determine if the dietary supplement, Berkeley Life Nitric Oxide, affects
the function of platelets. Platelets play a negative role in heart disease. We will
determine if nitric oxide affects platelets in such a way as to reduce that negative
affect.
View Study Details
Study of BHV-4157 in Alzheimer's Disease
Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect
patients from
AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg,
or
placebo, taken orally once daily. Duration of treatment is 48 weeks. There is also
a
screening period of up to 42 days; and a 4-week post-treatment observation period.
View Study Details
Study of Immunotherapy + Radiation in Soft Tissue Cancer
Lead Researcher: Deepak Sahasrabudhe
The main aim of immunotherapy is to enable patients' immune system to target cancer
cells and destroy them. This study will treat patients with soft tissue sarcoma (cancer)
with neoadjuvant nivolumab and ipilimumab, antibodies that can be used as immunotherapies.
Patients will also receive concurrent radiation therapy. Following these treatments
will be the surgical removal of the patent's soft tissue sarcoma.
View Study Details
Study of Kidney Tumors in Younger Patients
This research trial studies kidney tumors in younger patients. Collecting and storing
samples
of tumor tissue, blood, and urine from patients with cancer to study in the laboratory
may
help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and
identify
biomarkers related to cancer.
View Study Details
Study of Peptide Vaccine in Treating Patients with Newly Diagnosed Plasma Cell Leukemia
Lead Researcher: Brea Lipe
This study looks at treating patients with newly diagnosed multiple myeloma (plasma
cell leukemia) who are receiving lenalidomide maintenance therapy, a kind of maintenance
chemotherapy. Specifically, this study will look at the safety of SVN53-67/M57-KLH
peptide vaccine in incomplete Freund's adjuvant together with sargramostim. This
peptide vaccine may help the body build an effective immune response to kill certain
cancer cells. Incomplete Freund's adjuvant may help stimulate the body's immune response
to the vaccine treatment. Sargramosti may increase the production of blood cells.
Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth. Giving SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant
and sargramostim before or after the start of lenalidomide maintenance therapy may
be a better treatment for multiple myeloma.
View Study Details
Study of Testosterone and rHGH in FSHD
Lead Researcher: Elizabeth Luebbe
The purpose of this study is to investigate the safety and tolerability of combination
therapy with recombinant human growth hormone (rHGH) and testosterone in adult male
patients
with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.
View Study Details
Study of the drug acalabrutinib and antibody rituximab in patients with leukemia or
lymphoma
Lead Researcher: Paul Barr
Despite an array of available therapies, chronic lymphocytic leukemia (CLL) remains
an incurable disease. The development of an improved therapy would be a major contribution
to the management of CLL and other B cell malignancies.
The investigator proposes that the drug acalabrutinib will work better with an antibody
treatment, rituximab, in the treatment of CLL.
View Study Details
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate
to Severe Ulcerative Colitis
Ulcerative colitis is an inflammatory bowel disease (IBD) that causes long-lasting
inflammation and ulcers (sores) in your digestive tract. Ulcerative colitis affects
the innermost lining of your large intestine (colon) and rectum. The purpose of this
study is to determine whether PF-06651600 and PF-06700841 are effective
in treatment of moderate to severe ulcerative colitis.
View Study Details
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years
and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment
in Flaring Subjects
Lead Researcher: Lisa Beck
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and
over
with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis.
Subjects
responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg)
taken
orally once daily (QD) will be identified and randomized in a double-blind manner
to receive
200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of
2 doses
of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing
significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks
rescue
treatment and receive 200 mg PF-04965842 together with a marketed topical medicine.
Eligible
patients will have the option to enter a long-term extension study after completing
the
initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
View Study Details
Studying Infant Nutrition and Blood Sugar in Breastfed Infants
Lead Researcher: Bridget Young
This study is for pregnant women who plan on breastfeeding their baby for at least
5 months. You and your baby will have two study visits over the first 6 months of
your baby's life at the University of Rochester Medical Center. We will ask for some
blood and some breast milk from you. We will ask for some urine and stool, and a heel
prick from your baby.
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Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed
or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders
(The Pediatric MATCH Screening Trial)
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well
treatment
that is directed by genetic testing works in pediatric patients with solid tumors,
non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at
least one
line of standard systemic therapy and/or for which no standard treatment exists that
has been
shown to prolong survival. Genetic tests look at the unique genetic material (genes)
of
patients' tumor cells. Patients with genetic changes or abnormalities (mutations)
may benefit
more from treatment which targets their tumor's particular genetic mutation, and may
help
doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
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The Couples Sexual Health Study
Lead Researcher: Natalie Leblanc
The purpose of this study is to better understand Black Heterosexual couples' thoughts
and suggestions of an online Sexual Health HIV Prevention Toolkit that has been originally
designed for male couples to use together The toolkit is to guide couples to think
about their relationship, their relationship goals and their sexual health in order
to reduce being exposed to sexually transmitted infections including HIV, and create
a plan for optimal sexual health.
The toolkit is to also help guide couples to come to an agreement of their sexual
and relationship goals.
We are very interested in finding out whether an online sexual health toolkit that
has been found to be acceptable to gay male couples would be accepted by Black heterosexual
couples.
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The LGBTQI parental experience with newborn nutrition
Lead Researcher: Rita Dadiz
Eligible participants include parents of a newborn child born within the past 1 year
from time of recruitment. Parents must have identified as LGBTQI during the birthing
and initial newborn hospitalization period. Adopted parents are eligible if they were
involved in the birthing process. Parents must be at least 18 years old.
The study includes two brief surveys which can be done online or on paper and a 60-90
minute interview done either in person or through video conferencing.
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The REPLACE Registry-for people who take Cholbam/Kolbam (Cholic Acid)
Lead Researcher: Nanda Kerkar
This is a study for people who take Cholbam/Kolbam also known as Cholic acid. You
will be in this study for 10 years and we will collect information about your health.
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The Role of Microparticles as a Biomarker
The investigators propose to characterize MPs in aHUS and TTP both at the onset and
throughout treatment. The investigators believe that the number, size, and cell origin
of MPs
will differ between these two diseases. The hypothesis is that endothelial derived
MPs will
be higher in number and comprise a larger portion of the MP population in aHUS and
that
platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The
investigators believe that MP identity and number can be used to reliably differentiate
between aHUS and TTP at disease onset.
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The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome
Study
The purpose of this study is to examine the treatment, both surgical and non-surgical,
of
patients with any form of early onset scoliosis. Such treatment may include the use
of growth
friendly devices that are surgically or magnetically lengthened; or the use of serial
body
casting or bracing, or observation. Outcomes examined will be what can be seen physically
on
the patient and on x-ray, as well as parent perception of how the treatment effects
their
child with the use of a health-related quality of life (HRQOL) questionnaire.
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Therapy for Moderate to Severe Ulcerative Colitis (UC)
Lead Researcher: Lawrence Saubermann
Participation will last just under 1 year. Subjects will be randomized to either receive
a dose of either the PF1600 or PF841 study drug or placebo pill for the first 8 weeks,
and then they will be re-randomized to take one set dose of either study drug or placebo
pill for the remaining 24 weeks. Subjects will need to visit the clinic for study
related procedures at least 10 times. Colonoscopies are required.
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Tissue Bank Study for Thrombotic Thrombocytopenic Purpua
Lead Researcher: Frank Akwaa
Thrombotic Thrombocytopenic Purpura (TTP) is a rare blood disease that can affect
some people once, but it can be a recurrent problem with chronic issues for others.
This study will help us understand why this is the case. Blood samples and data will
be stored and used in the future to learn more about this condition.
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To determine how flu causes symptoms and how the immune system responds to flu infection
Lead Researcher: Angela Branche
THIS STUDY IS BEING DONE TO DETERMINE HOW IMMUNE SYSTEM RESPONDS IN PEOPLE AND IS
THE IMMUNE RESPONSE DIFFERENT IN ADULTS AS COMPARED TO CHILDREN
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Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation
Positive Non-small Cell Lung Cancer
This phase II trial studies how well trametinib and docetaxel work in treating patients
with
stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come
back.
Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell
growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop
the
growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by
stopping them from spreading. Giving trametinib with docetaxel may work better in
treating
non-small cell lung cancer.
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Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds
for
transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement
in the
primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26
months
of age, using standardized assessments by Bayley.
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Treatment Alternatives in iSGS (NoAAC PR-02 Study)
The study is aimed at answering the questions; (1) How well do the most commonly used
treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with
each
approach?
With the results of this trial, the investigators hope to provide information to iSGS
patients: (1) Given my personal characteristics, conditions, and preferences, what
should I
expect will happen to me? and (2) What are my options, and what are the potential
benefits
and harms of these options?
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Treatment of Acute Lymphoblastic Leukemia in Children
RATIONALE: L-asparaginase is an important component of treatment for childhood acute
lymphoblastic leukemia, but is also associated with notable side-effects, including
hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients
with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued
because of
intolerable side-effects had survival outcomes that were inferior to those who received
all
or nearly all of their intended doses. Two bacterial sources of asparaginase exist:
Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived
enzyme has been used as front-line therapy and the Erwinia-derived preparation has
been
reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase
(PEG-asparaginase) has a longer half-life and is potentially less immunogenic than
native E
coli L-asparaginase, and has been used as the initial asparaginase preparation in
some
pediatric acute lymphoblastic leukemia treatment regimens.
PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations:
intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase
(IM-EC)
have been well characterized, their relative efficacy and toxicity have not been studied
extensively.
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Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic
Leukemia
This phase III trial studies tretinoin and arsenic trioxide in treating patients with
newly
diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic
leukemia
involves high doses of a common class of chemotherapy drugs called anthracyclines,
which are
known to cause long-term side effects, especially to the heart. Tretinoin may stop
the growth
of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide
may
stop the growth of cancer cells by either killing the cells, by stopping them from
dividing,
or by stopping them from spreading. Completely removing or reducing the amount of
anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may
be an
effective treatment for acute promyelocytic leukemia and may reduce some of the long-term
side effects.
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trūFreeze® Palliative Esophageal Cancer
Lead Researcher: Vivek Kaul
Prospective, open label, non-controlled single arm, multi-center study.
The primary objective is to study the effects of the trūFreeze® Spray Cryotherapy
System in a population of subjects who have been diagnosed with persistent local esophageal
cancer and who are not surgical candidates or have completed or declined systemic
therapy.
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Umbilical Cord Blood Transplantation from Unrelated Donors
Lead Researcher: Jane Liesveld
This study is a single-center treatment protocol with four possible preparative regimens,
designed to validate the process of umbilical cord blood stem cell transplantation
at our institution. Enrolled patients will receive chemotherapy +/-total body radiation
as a pre-transplant conditioning regimen. Patients will then receive cord blood stem
cells followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate
Mofetil, or Cyclosporin A and Methylprednisolone. Multiple data points will be collected
prior to, during, and following transplantation to ensure safety of the process and
to evaluate the stated objectives.
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Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With
Low Ejection Fraction
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted
with
the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of
sudden
cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp
in order
to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The
incidence
of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks
observed in the MADIT RIT study.
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Upper GI Tract Cancer: 12 week home-based exercise study
Lead Researcher: Richard Dunne
We would also like to find out if this exercise intervention improves physical performance,
day-to-day function, quality of life, and how the exercise may affect markers of inflammation
in the blood over time.
Cancer cachexia is a complex condition that can result in weight loss, muscle weakness,
and/or tiredness, and may affect your normal daily activities and quality of life.
Cachexia is common in patients with upper gastrointestinal tract cancers (esophageal,
stomach, bile duct or liver cancer, and pancreatic cancer). There is little information
on how these symptoms may develop or change as cachexia progresses, or how exercise
may help improve these symptoms. Currently more information is needed on how physical
performance and quality of life is affected by cachexia. There are no drugs approved
for cachexia so understanding cachexia and its effect on the body may guide the development
of interventions to help other patients with cancer cachexia.
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URMC Related Haplo-identical Donor BMT (HaploOnly)
Lead Researcher: Jeffrey Andolina
This study will be a single-center treatment protocol with five possible preparative
regimens, designed to validate the process of related donor haploidentical-SCT at
the Wilmot Cancer Institute Blood and Marrow Transplant Unit. Enrolled patients will
receive chemotherapy +/- radiation as a pre-transplant conditioning regimen. Patients
will then receive haploidentical stem cells, either bone marrow or mobilized peripheral
blood, followed by GvHD prophylaxis that will include cyclophosphamide. Multiple data
points will be collected prior to, during, and following transplantation to ensure
safety of the process and to evaluate the stated objectives.
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Using An Investigational Drug to Treat Non-Diabetic Nerve Pain ("TopCSPN")
Lead Researcher: Peter Creigh
Many people experience nerve pain and tingling in their hands and feet that has a
known cause, such as diabetes. When there is no identifiable medical reason for the
nerve pain (‘neuropathy’) you are experiencing, it is called Cryptogenic Sensory Peripheral
Neuropathy, “CSPN,” for short. This study is a double blind, randomized placebo-controlled
trial of topiramate at a target dose of 100 mg daily for 96 weeks as a potential therapy
for the nerve pain of CSPN. Topiramate is the Investigational Drug in this study.
Topiramate is approved by the US Food and Drug Administration for prevention of migraines
and seizures, but not for the treatment of nerve pain. Study participants will be
randomized 1:1 to topiramate or placebo (sugar pill). Neither participants nor the
Study Team will know which group participants are in. All participants will return
to the clinic for follow up visits once every 16 weeks for evaluation. Evaluations
will include assessments and questionnaires to determine if topiramate improves symptoms
of CSPN and makes your life better.
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Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing
Loss
This is an international, multi-center, double-blind, placebo-controlled evaluation
valganciclovir treatment for up to 54 children (up to 4 years of age) with
virologically-confirmed congenital CMV infection and hearing loss. Subject participation
will
be over a six-month period and study subjects will be stratified according to age.
The
primary objective is to assess whether a six-week course of oral valganciclovir can
stabilize
the hearing of children with congenital CMV infection who present with hearing loss.
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Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally
Advanced Rectal Cancer
This randomized phase II trial studies how well veliparib or pembrolizumab work with
combination chemotherapy and radiation therapy in treating patients with rectal cancer
that
has spread from where it started to nearby tissue or lymph nodes (locally advanced).
Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell
growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability
of tumor
cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6
regimen,
work in different ways to stop the growth of tumor cells, either by killing the cells,
by
stopping them from dividing, or by stopping them from spreading. Radiation therapy
uses
high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib or pembrolizumab
with combination chemotherapy and radiation therapy may kill more tumor cells, make
the tumor
smaller, and reduce the amount of normal tissue that needs to be removed.
View Study Details
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric
MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well vemurafenib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations
that have spread to other places in the body and have come back or do not respond
to
treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the
enzymes
needed for cell growth.
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Vision-based Speed of Processing Cognitive Training and Mild Cognitive Impairment
This project seeks to identify neural changes that occur in adults with mild cognitive
impairment (MCI) after engagement in computerized cognitive training. In addition,
this
project aims to identify physiological factors that may bolster effects of the training
on
cognitive function. Individuals with MCI are at high risk for Alzheimer's disease
(AD).
Understanding how cognitive training protects cognitive function in MCI can contribute
to
development of effective interventions to slow progression to AD in individuals at
risk,
thereby reducing the significant morbidity and health care costs associated with AD.
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Vitamin D Dynamics in Women
Lead Researcher: Eva Pressman
The goal of this pilot project is to utilize stable isotopically labeled vitamin D3
and state
of the art mass spectrometric methodology to assess vitamin D dynamics during pregnancy
in
relation to calcitropic hormone status at this key life stage. At the conclusion of
this
study, the investigators will have obtained novel information on the absorption and
utilization of vitamin D in women and determined if maternal vitamin D3 or maternal
25(OH)D3,
or both, can be transferred across the placenta to the fetus. The long-term goal is
to better
understand the unique metabolism of vitamin D during pregnancy.
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VX15/2503 Treatment for Huntington's Disease
The purpose of this study is to evaluate the safety, tolerability, PK, and efficacy
of
VX15/2503 in subjects with late prodromal and early manifest Huntington's disease.
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Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib
Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic
radiosurgery with or without lapatinib ditosylate works in treating patients with
breast
cancer that has too many of a protein called human epidermal growth factor receptor
2 (HER2)
on its cells and has spread to the brain. Radiation therapy uses high energy x rays
to kill
tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation
therapy
that delivers a single, high dose of radiation directly to the tumor and may kill
more tumor
cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth
of
tumor cells by blocking some of the enzymes needed for cell growth. It is not yet
known
whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib
ditosylate is an effective treatment for brain metastasis from breast cancer.
View Study Details
Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Treating Patients
With Limited Stage or Extensive Stage Small Cell Lung Cancer
This randomized phase II/III trial studies how well whole-brain radiation therapy
works and
compares it with or without hippocampal avoidance in treating patients with small
cell lung
cancer that is found in one lung, the tissues between the lungs, and nearby lymph
nodes only
(limited stage) or has spread outside of the lung in which it began or to other parts
of the
body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells
and
shrink tumors. The hippocampus is part of the brain that is important for memory.
Avoiding
the hippocampus during whole-brain radiation could decrease the chance of side effects
on
memory and thinking. It is not yet known whether giving whole-brain radiation therapy
is more
effective with or without hippocampal avoidance in treating patients with small cell
lung
cancer.
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Whole-Food, Plant-Based Nutrition Among Women with Metastatic Breast Cancer
Lead Researcher: Thomas Campbell
Women will be given free, prepared food for 8 weeks, along with a multivitamin, and
will attend weekly office visits. Women will be assessed at the beginning of the study
and after eating the food for 8 weeks, in addition to a blood test after 3 weeks.
There will also be a Control Group of women that will eat their regular diet and take
a provided multivitamin.
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Zenith® Low Profile AAA Endovascular Graft
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial
to study
the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used
in
conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic,
aortoiliac, and iliac aneurysms.
View Study Details