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.
Blood Cancer: Dose-Escalation Study of VLS-101
Lead Researcher: Paul Barr
This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics,
immunogenicity, and efficacy of the novel drug, VLS-101, across a range of dose levels
when administered to subjects with previously treated relapsed or refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular
lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma, or Richter transformation
lymphoma.
View Study Details
Pembrolizumab with Lenvatinib vs. Docetaxel in Participants with Lung Cancer Growth
After Chemotherapy and Immunotherapy
Lead Researcher: Ronald Maggiore
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib
(E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung
cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and
treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses
of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs:
1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central
review (BICR).
View Study Details
Standard Combination Therapy with Niraparib in Treating Patients with Prostate Cancer
Lead Researcher: Hong Zhang
This phase II trial studies the side effects and best dose of niraparib, and to see
how well it works in combination with standard of care radiation therapy and hormonal
therapy (androgen deprivation therapy) in treating patients with prostate cancer that
has a high chance of coming back (high risk). Niraparib may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth. Adding niraparib to
the usual treatments of radiation therapy and hormonal therapy may lower the chance
of prostate cancer growing or returning.
View Study Details
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Mantle
Cell Lymphoma
Lead Researcher: Patrick Reagan
This phase II trial compares three chemotherapy regimens consisting of bendamustine,
rituximab, high dose cytarabine, and acalabrutinib and studies how well they work
in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy,
such as bendamustine and cytarabine, 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. Monoclonal antibodies, such as rituximab, may interfere with
the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth
of cancer cells by blocking some of the enzymes needed for cell growth. This study
is being done to find out if the drug combinations of bendamustine, rituximab, high
dose cytarabine, and acalabrutinib is better or worse than the usual approach for
mantle cell 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 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer
Lead Researcher: Marcus Noel
A prospective, open-label phase 2 trial in metastatic pancreatic cancer subjects who
have failed at least one line of any prior chemotherapy. The trial is designed to
evaluate the of SM-88 therapy on pancreatic cancer and will measure multiple efficacy
and safety endpoints, including overall response rate, overall survival, progression
free survival, relevant biomarkers, quality of life and safety. In the initial stage
of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative will
be evaluated.
View Study Details
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic
Leukemia
Lead Researcher: Angela Girvin
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 Pilot Study of the Combination of Entinostat with Capecitabine in Breast Cancer
Lead Researcher: Ajay Dhakal
The purpose of this study is to learn about the safety and side effects of combining
entinostat, an investigational drug, with capecitabine, a drug commonly used in breast
cancer (BC) - in both participants with metastatic breast cancer (MBC) and then participants
with high-risk breast cancer after neo-adjuvant therapy.
View Study Details
A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
Lead Researcher: Brea Lipe
This trial will study SEA-BCMA, a monoclonal antibody, to find out whether it is an
effective treatment for multiple myeloma (MM) and what side effects (unwanted effects)
may occur. The study will have two parts. Part 1 of the study will find out how much
SEA-BCMA should be given for treatment and how often. Part 2 of the study will use
the dose found in Part 1 and look at how safe and effective the treatment is.
View Study Details
A study combining two drugs, Daratumumab and Lenalidomide as Maintenance Therapy for
Patients with Multiple Myeloma
Lead Researcher: Brea Lipe
Patients will be treated with Daratumumab and Lenalidomide or Lenalidomide alone for
two years and then tested for minimal residual disease. Minimal residual disease
is the evidence for the presence of residual malignant cells, even when so few cancer
cells are present that they cannot be found by routine means. In a patient who has
been treated, the detection of MRD indicates that treatment is incomplete. MRD can
thus distinguish who needs intensive and potentially more toxic therapy from those
who do not. After 2 years of Maintenance, MRD is assessed to guide further therapy.
MRD-positive patients will continue with the assigned treatment. MRD-negative patients
will be either continue or discontinue the assigned treatment. Patients are treated
for up to 7 years and followed for up to 15 years.
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 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 DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies
Lead Researcher: Nimish Mohile
This is a dose-escalation study of DSP-7888 Dosing Emulsion administered to adult
patients with advanced malignancies. Patients will be administered escalating doses
of DSP-7888 Dosing Emulsion intradermally (between the skin layers) or subcutaneously
(under the skin) in accordance with the following regimen: once weekly for four weeks
during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation
Phase, and once every 14 to 28 days until a discontinuation criterion is met during
the Maintenance Phase.
Once the highest dose with acceptable toxicity is determined from either the intradermal
or subcutaneous group, an additional 40 patients may be enrolled as an expansion cohort
at this dose and route of administration to confirm safety and tolerability.
Separate from the dose-ascending cohort and expansion cohort described previously,
and once the intradermal dose-ascending cohort is completed, up to 20 myelodysplastic
syndrome (MDS) patients who are resistant to treatment with hypomethylating agents
(HMAs) will be enrolled into an MDS expansion cohort. Of these 20 MDS patients, one-half
will receive DSP-7888 at 10.5 mg according to the modified schedule employed in Phase
1 (every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks [Named
MDS Cohort 1]). The other half of the MDS patients will receive DSP-7888 at 10.5 mg
in an alternative dosing schedule where DSP-7888 is administered every 2 weeks until
Week 24, after which it will be administered every 4 weeks (Named MDS Cohort 2).
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 Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed
Multiple Myeloma
Lead Researcher: Brea Lipe
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 Immune Responses to the Virus That Causes COVID-19
Lead Researcher: Michael Keefer
This study will help us learn how the body's immune system responds to the SARS-CoV-2
virus. Some people know this virus by the name "coronavirus." It can cause the disease
called COVID-19. The information gained from the study can be used to help develop
better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing
future vaccines, other prevention strategies, and treatments.
View Study Details
A Study of IMO-2125 in Combination With Ipilimumab in Subjects With Melanoma (ILLUMINATE-301)
Lead Researcher: Deepak Sahasrabudhe
A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without
intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease
progression while on nivolumab or pembrolizumab
View Study Details
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma
Lead Researcher: Adrienne Victor
The purpose of this study is to assess the clinical activity and safety of INCMGA00012,
a monoclonal antibody, in participants with metastatic merkel cell carcinoma (MCC).
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 (an
injection under the skin) in participants with Crohn's disease.
Inclusion Criteria: Have Crohn's disease or fistulizing Crohn's disease for at least
3 months duration (a minimum of 12 weeks). Have demonstrated intolerance or inadequate
response to conventional or biologic therapy for Chrohn's disease.
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)
Lead Researcher: Lawrence Saubermann
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 Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in
Patients With Head/Neck Cancer
Lead Researcher: Ronald Maggiore
The purpose of the phase 3, clinical study is to determine if GC4419 administered
prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation
induced oral mucositis in patients who have been diagnosed with locally advanced,
non-metastatic squamous cell carcinoma of the head and neck.
View Study Details
Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric
and Adult Patients With Germ Cell Tumors
Lead Researcher: Angela Girvin
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): 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
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
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
Researchers are seeking to understand how two standard topical treatments for atopic
dermatitis
affect patient-reported outcomes (itch, pain, sleep, mood, and quality of life) and
parent/caregiver
quality of life. Participation will last approximately 12 weeks, which will include
3 clinic visits at UR Dermatology for clinical assessment of atopic dermatitis and
the completion of electronic questionnaires by the child with atopic dermatitis and
a parent/caregiver. Payment for participation is up to $130 if all visits are completed.
You may be eligible if: You have a child between 2 to 15 years of age with a clinical
diagnosis of mild to moderate Atopic Dermatitis. Your child does not have a diagnosis
of another skin disease.
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
Assessment of Patients with Brain Tumors, Ages 65+
Lead Researcher: Andrea Wasilewski
The purpose of this study is to collect information about the physical function,
thinking, independence, social support, and medications of older patients with brain
tumors in order to develop more specialized treatments and support for that
population. Inclusion Criteria: Age 65 or older of any race, ethnicity, or gender;
Pathologically confirmed glioblastoma or anaplastic astrocytoma; Have not started
radiation or chemotherapy for brain tumor treatment
View Study Details
Axillary Reverse Mapping in Preventing Lymphedema (Swelling) in Patients With Breast
Cancer
Lead Researcher: Kristin Skinner
This phase III trial studies how well axillary reverse mapping, a visualization technique
with a blue dye, works in preventing lymphedema (a swelling condition) in patients
with breast cancer that are undergoing dissection of lymph nodes in the armpit. Axillary
reverse mapping may help to preserve the lymph node drainage system around the breast
so as to prevent lymphedema after surgery.
View Study Details
B-Cell Acute Lymphoblastic Leukemia: Adding Inotuzumab Ozogamicin to Chemotherapy
Lead Researcher: Angela Girvin
Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type
of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted
way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy
regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin,
methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and
pegaspargase 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.
The overall goal of this study is to understand if adding inotuzumab ozogamicin to
standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute
Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first
two phases of therapy: Induction and Consolidation. This part will collect information
on the leukemia, as well as the effects of the initial treatment, in order to classify
patients into post-consolidation treatment groups. On the second part of this study,
patients will receive the remainder of the chemotherapy cycles (interim maintenance
I, delayed intensification, interim maintenance II, maintenance), with some patients
randomized to receive inotuzumab.
View Study Details
Biomarker/ALK Inhibitor Combinations in Treating Patients With Lung Cancer
Lead Researcher: Ronald Maggiore
This National Cancer Institute (NCI)-NRG phase II trial studies how well a combination
of different biomarker/ALK inhibitors work in treating patients with stage IV, ALK
positive, non-squamous, non-small cell lung cancer.ALK inhibitors like lorlatinib,
ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in
chemotherapy, such as pemetrexed, 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. It is not yet known whether a combination
of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with
lung cancer.
View Study Details
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma
or Ganglioneuroblastoma
Lead Researcher: Angela Girvin
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 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: 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
Bladder Cancer: Study of Pembrolizumab With or Without Platinum-based Combination
Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma
Lead Researcher: Elizabeth Guancial
If you agree to and are allowed to participate in this study, you will be assigned
by 33% chance (a process called randomization similar to rolling a dice) to one of
three treatment groups:
• Subjects assigned to Treatment Group A, will receive pembrolizumab
• Subjects assigned to Treatment Group B, will receive the combination of pembrolizumab
and chemotherapy (either cisplatin or carboplatin with gemcitabine).
• Subjects assigned to Treatment Group C, will receive chemotherapy (either cisplatin
or carboplatin with gemcitabine).
Both you and your doctor will know which treatment group you have been assigned to.
View Study Details
Bladder Cancer: study on a drug delivery system (TAR-200)
Lead Researcher: Chunkit Fung
TAR-200 is a drug-device product that continuously releases a chemotherapy drug (called
gemcitabine) in the bladder over several days. The purpose of this study is to determine
if TAR-200, when combined with a first-line treatment (a drug called nivolumab) is
safe and tolerable in patients with muscle-invasive bladder cancer (MIBC).
View Study Details
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic
Leukemia
Lead Researcher: Angela Girvin
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
Blood Cancer: A Study of APTO-253 in Patients With Acute Myelogenous Leukemia (AML)
or Myelodysplastic Syndrom (MDS)
Lead Researcher: Kristen O'Dwyer
This study is being done to evaluate the safety and effectiveness of APTO-253 for
the treatment of patients with the condition of acute myelogenous leukemia (AML) or
myelodysplastic syndrome (MDS) for which either the standard treatment has failed,
is no longer effective, or can no longer be administered safely or poses a risk for
your general well being.
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 Weight Loss Study (BWEL Study)
Lead Researcher: Kristin Skinner
This randomized phase III trial studies whether weight loss in overweight and obese
women may prevent breast cancer from coming back (recurrence). Previous studies have
found that women who are overweight or obese when their breast cancer is found (diagnosed)
have a greater risk of their breast cancer recurring, as compared to women who were
thinner when their cancer was diagnosed. This study aims to test whether overweight
or obese women who take part in a weight loss program after being diagnosed with breast
cancer have a lower rate of cancer recurrence as compared to women who do not take
part in the weight loss program. This study will help to show whether weight loss
programs should be a part of breast cancer treatment.
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: Predictors of Chemotherapy Side Effects in Older Adults
Lead Researcher: Supriya Mohile
The purpose of this study is to understand how a person’s physical function (ability
to complete daily activities at home and in the community) changes over time.
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
Cabozantinib S-Malate in Treating Patients With Neuroendocrine Tumors
Lead Researcher: Aram Hezel
This randomized phase III trial studies cabozantinib S-malate to see how well it works
compared with placebo in treating patients with neuroendocrine tumors that have spread
to nearby tissues or lymph nodes, have spread to other places in the body, or cannot
be removed by surgery after previous treatment with everolimus. Cabozantinib S-malate
is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific
tyrosine kinase receptors, that when blocked, may slow tumor growth.
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
Cancer: Geriatric Assessment and Clinical Outcomes in Older Oncology Patients (SOCARE)
Lead Researcher: Supriya Mohile
We are asking for your participation in this study not as consent to undergo this
testing (as it is undertaken for all new patients), but so that we may follow your
evaluation results, and determine how this testing influences our shared decisions
regarding your care and treatment. This information is useful, as it is understood
that older patients (greater than or equal to 65-years old) often have different levels
of health, and outside challenges that can influence their care. Historically, older
patients have not received equal treatment for cancer and may be at greater risk for
possible side effects from treatment. It is our hope that these tools, well-established
at identifying areas of risk, will provide meaningful opportunities of intervention
that will promote your safety.
View Study Details
Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From
COVID-19
Lead Researcher: Michael Keefer
The purpose of this study is to learn more about infection with and recovery from
the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some
people know this virus by the name "coronavirus." It can cause the disease called
COVID-19.
The information gained from the study will be used to help develop better tests for
SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines
and treatments by allowing researchers to determine the difference between the body's
immune
response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.
Inclusion Criteria: Age 18 or older / Have had a positive test for SARS-CoV-2 / Reports
resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection,
reports positive SARS-CoV-2 test within 2-10 weeks of enrollment.
View Study Details
Chemoradiotherapy with Atezolizumab (Monoclonal Antibody) for Treating Bladder Cancer
Lead Researcher: Yuhchyau Chen
This phase III trial studies how well chemotherapy and radiation therapy work with
or without atezolizumab in treating patients with localized muscle invasive bladder
cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors.
Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C,
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 chemotherapy
with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies,
such as atezolizumab, may help the body's immune system attack the cancer, and may
interfere with the ability of tumor cells to grow and spread. Giving atezolizumab
with radiation therapy and chemotherapy may work better in treating patients with
localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy
without atezolizumab.
View Study Details
Chronic Pain Study
Lead Researcher: Paul Geha
This study will use subjective rating methods, computer-based games, and brain imaging
to study the characteristics of chronic pain and brain processes that cause them.
By so doing we hope to obtain new information and understanding of chronic pain across
multiple conditions.
Eligibility: Ages 18-65; in generally stable health; diagnosed with a pain condition:
Chronic back pain (CBP), Osteoarthritis of the knee (OAk), Temporomandibular joint
disorder(TMJ), Complex regional pain syndrome (CRPS), or Pelvic Pain (PP).
View Study Details
Collecting Breast Milk Samples for Future Research
Lead Researcher: Kirsi Jarvinen-seppo
When some research ideas are initially formed, they need to be tested on small amounts
of human breast milk before moving on to large studies. This study will collect a
one-time breast milk sample and questionnaire from each participant for that purpose.
Participants will be compensated $5 per breast milk sample (up to 4 samples). Additionally,
this study will collect multiple breast milk samples from two different groups of
mothers who can collect samples at home. The first group will help us learn more about
food allergies by collecting samples before a meal and 1, 2, 6, and 24 hours after
a meal containing one egg, one cup of milk, or a small handful of peanuts. If a woman
is experiencing COVID-19 symptoms, they may join a different group that will provide
samples over time to help us learn how long the virus is present in breast milk.
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: 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
Combination Treatment for Lung Cancer with STK11 Gene Mutation
Lead Researcher: Megan Baumgart
This phase II LUNG-MAP treatment trial studies how well combination treatment (talazoparib
plus avelumab) works in treating patients with non-squamous non-small cell lung cancer
that has an STK11 gene mutation and has come back (recurrent) or is stage IV. Talazoparib
may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. Immunotherapy drugs given as single therapies or in combination
with chemotherapy do not appear to work as well in lung cancer cells with mutations
in the STK11 gene versus those that do not have the mutation. Adding the medicine
talazoparib to the immunotherapy drug avelumab may work better in treating lung cancers
that have an STK11 gene mutation.
View Study Details
Combining Immune Therapy, Pembrolizumab, and Chemotherapy as First Line Treatment
for Lung Cancer
Lead Researcher: Megan Baumgart
The purpose of this study is to understand if treatment with one chemotherapy medication
combined with immune therapy (pembrolizumab) is tolerable and effective for patients
with lung cancer and performance status of 2 (PS2), which means you have limitations
in carrying out certain activities or spend up to half of your day resting.
View Study Details
CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-Surgery
Chemo and Targeted Therapy
Lead Researcher: Ajay Dhakal
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating
further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast
cancer who have no cancer remaining at surgery (either in the breast or underarm lymph
nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy,
such as 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.
Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work
by attaching themselves to specific molecules (receptors) on the surface of tumor
cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals
that tell the cells to grow are blocked and the tumor cell may be marked for destruction
by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable
fewer chemotherapy drugs to be given without compromising patient outcomes compared
to the usual treatment.`
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
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Lead Researcher: Martin Zand
This study will determine if plasma collected from the blood of people who have recovered
from COVID-19 infection will help others who are at risk for getting COVID-19. Participants
should be people who are at high risk for COVID-19 infection. They will receive a
one-time infusion of plasma from a person who has recovered from a COVID-19 infection.
Plasma will not have COVID-19 but will have antibodies to the virus. The purpose
of this study is to determine if these antibodies will help keep people who are at
high risk for getting COVID from getting infected. To be eligible you must have had
close contact with someone who is COVID-19 positive and have a high risk for illness
such as >=65, reside in a nursing home or long-term care facility, have chronic lung
disease, asthma, heart disease, obesite, uncontrolled diabetes, renal failure, liver
disease or cancer. Or you must be a healthcare professional with high risk exposure
such as have had prolonged close contact with patients with COVID-19 who were not
wearing a facemask while HCP nose and mouth were exposed to material potentially infectious
with the virus causing COVID-19.
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
Describing the Infection/Illness Mechanisms for Influenza and COVID-19
Lead Researcher: Angela Branche
This study will obtain timed samples of blood and nasal secretions from adults, children,
and the elderly with influenza-like illness. It will look to characterize the pathogenesis
(mechanisms of infection/illness) and the responses that occur within the immune system
- for both COVID-19 and influenza.
View Study Details
Developmental Impact of NICU Exposures (DINE)
Lead Researcher: Gloria Pryhuber
Entry into the DINE study requires prior enrollment in the Prematurity and Respiratory
Outcomes Program (PROP) or the Impact of Respiratory Virus Infections and Bacterial
Microbiome Shifts/PRISM study. If you have not participated in these studies in the
past you will not be eligible for this trial.
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
Diffuse Large B-Cell Lymphoma (DLBCL): A Study of Brentuximab Vedotin Incorporated
into Reduced-Dose Chemotherapy in Elderly Patients
Lead Researcher: Patrick Reagan
This study incorporates brentuximab vedotin into dose-reduced chemotherapy (rituximab,
cyclophosphamide, doxorubicin, and prednisone) as initial therapy for elderly patients
with Diffuse Large B-Cell Lymphoma (DLBCL). Vincristine, which is typically part of
the standard chemotherapy regimen, will be omitted due to overlapping toxicities with
brentuximab vedotin.
View Study Details
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive,
Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and
Taxane [DESTINY-Breast03]
Lead Researcher: Alissa Huston
This study is designed to compare the anti-tumor activity as well as the safety and
efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic
breast cancer subjects previously treated with trastuzumab and taxane
View Study Details
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy
and Heart Failure After Cancer Treatment
Lead Researcher: Angela Girvin
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
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
Engage Coaching to Promote Connectedness in Caregivers
Lead Researcher: Kimberly Van orden
Adults (age 50 or older) who are providing care for someone with dementia will participate
in what we call ‘Engage Coaching.’ This involves meeting with an Engage Coach up to
8 times. Typically, meetings will occur weekly, but you will have up to three months
to complete your sessions. These meetings are brief (approximately 30 mins) and can
be done in your home or wherever is convenient for you, including via phone if needed.
The coaching is designed to help you enhance your relationships and improve well-being
while managing caregiving stress. Your coach will help you identify aspects of your
social relationships that are helpful to you and aspects that are not. Using this
information, your coach will help you identify goals for improving your social relationships.
Each session, your coach will help you complete a process we call ‘action planning,’
in which you set a goal for the week, brainstorm strategies to meet the goal, and
identify concrete steps to take to achieve the goal. You will work with your coach
to identify any aspects of caregiving that may present barriers to improving your
relationships and develop strategies to address these barriers. Participants will
also complete two follow-up interviews after completing the coaching--three months
after enrolling in the study (after completing Engage Coaching) and six months after
enrolling.
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)
Lead Researcher: Angela Girvin
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)
Lead Researcher: Angela Girvin
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
Evaluating Social Networks for Adults with Advanced Cancer: A Pilot Feasibility Study
Lead Researcher: Supriya Mohile
The purpose of this study is to learn how older adults with cancer seek information
from their
social networks (family, friends, clergy, or other people they are close with) and
how they use
information they’ve gathered to make decisions about treatment for their cancer.
View Study Details
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization
or Death in Persons With COVID-19
Lead Researcher: Christine Hurley
The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ)
and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult
outpatients with COVID-19 caused by SARS-CoV-2 infection.
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 Chemotherapy (Carboplatin) Dosing with Contrast Agent, Iohexol
Lead Researcher: Richard Moore
This trial studies how well iohexol, a contrast agent, works in helping doctors calculate
the dose of carboplatin given to patients with cancer. A contrast agent is a substance
used to increase the contrast of structures or fluids within the body in medical imaging.
Drugs used in chemotherapy, such as 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. Understanding how to best calculate the dose of
carboplatin given to patients with cancer may help doctors learn how to improve the
use of carboplatin in the future.
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
Future Contact Database/Repository for Allergy, Immunology, and Rheumatology Research
Lead Researcher: Jennifer Anolik
Autoimmune diseases affect the immune system and are typically chronic conditions
in which the immune system has an overactive response against substances and tissues
that are normally present in the body. How autoimmunity develops, progresses, induces
immunological abnormalities and leads to disease remains largely unknown, producing
the need for further research. However, because the necessary samples are unique and
somewhat rare, the ability to do research can at times be hindered.
One purpose of this protocol is to establish a database that will serve as both a
contact and research database. Subjects who are currently participating in one of
our studies as well as those who are interested in participating in future research
at the University of Rochester will be consented so that we may store their personal
information in a division database. We will also store data collected during the conduct
of IRB approved studies which reference this protocol.
Healthy controls and individuals with diseases affecting the immune system may be
consented and enrolled into this protocol.
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
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
Gilteritinib vs Midostaurin in Acute Myeloid Leukemia
Lead Researcher: Kristen O'Dwyer
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages
of 18 and 65 will be randomly assigned to receive gilteritinib or midostaurin. Patients
will also receive standard chemotherapy of daunorubicin and cytarabine.
Gilteritinib, is an oral drug that works by stopping the leukemia cells from making
the FLT3 protein. This may help stop the leukemia cells from growing faster and thus
may help make chemotherapy more effective. Gilteritinib has been approved by the Food
and Drug Administration (FDA) for patients who have relapsed or refractory AML with
a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its
use in this setting is considered investigational.
Midostaurin is an oral drug that works by blocking several proteins on cancer cells,
including FLT3 that can help leukemia cells grow. Blocking this pathway can cause
death to the leukemic cells. Midostaurin is approved by the FDA for the treatment
of FLT3 AML.
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin
in patients receiving standard combination chemotherapy for FLT3 AML.
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
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
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
Hematopoietic Stem Cell Transplantation: Evaluation of Investigational Cryopreserved
Cord Blood Units (CBUs)
Lead Researcher: Omar Aljitawi
The purpose of this study is to document and evaluate all problems that may occur
with the use of investigational cord blood units. This study will evaluate the safety
of administration of the investigational cord blood units by carefully documenting
all infusion-related problems. The cord blood units in this study have been collected,
processed, tested and stored by the National Cord Blood Program and meet the criteria
for transplantation as approved by NetCord-FACT (Foundation for the Accreditation
of Cellular Therapy).
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. Additionally, we may ask questions about social distancing,
so to that end this study is relevant to managing the psychosocial implications of
COVID-19. 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
Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With
Untreated Chronic Lymphocytic Leukemia
Lead Researcher: Paul Barr
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax
work in treating older patients with untreated chronic lymphocytic leukemia. Ibrutinib
may stop the growth of cancer cells by blocking some of the enzymes needed for cell
growth. Immunotherapy with obinutuzumab, may induce changes in body's immune system
and may interfere with the ability of cancer cells to grow and spread. Drugs used
in chemotherapy, such as venetoclax 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 ibrutinib and obinutuzumab with venetoclax may work better
at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
View Study Details
Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Patients With Chronic
Lymphocytic Leukemia
Lead Researcher: Paul Barr
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax
work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the
growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy
with monoclonal antibodies, such as obinutuzumab, may help the body's immune system
attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Drugs used in chemotherapy, such as venetoclax, 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 ibrutinib, obinutuzumab and venetoclax
may work better in treating patients with chronic lymphocytic leukemia.
View Study Details
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Lead Researcher: Angela Girvin
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 (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in
Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
Lead Researcher: Jonathan Friedberg
This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab
vedotin) when given with combination chemotherapy in treating patients with newly
diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal
antibodies, such as nivolumab, may help the body's immune system attack the cancer,
and may interfere with the ability of tumor cells to grow and spread. Brentuximab
vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin.
Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill
them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine,
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. The addition of
nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer
or extend the time without disease symptoms coming back.
View Study Details
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Lead Researcher: Deepak Sahasrabudhe
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
View Study Details
Immunotherapy in Treating Patients With Stage III-IV Skin Cancer
Lead Researcher: Adrienne Victor
This phase II trial studies how pembrolizumab works before and after surgery in treating
patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies,
such as pembrolizumab, may help the body's immune system attack the cancer, and may
interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab
before and after surgery may work better in treating melanoma.
View Study Details
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
Following enrollment, patients will be CD34+ stem cell mobilized with plerixafor,
at the discretion of the treating attending physician, for the achievement of >6 x10^6
CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not
be randomized and will subsequently be followed for disease progression and overall
survival.
Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the
hospital for planned autologous stem cell transplant (ASCT). Patients will be randomly
infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg.
Patients will receive standard supportive measures (including: growth factor support
post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion
and treatment for neutropenic fever) as per institutional guidelines.
View Study Details
Improving Risk Assessment of Acute Myeloid Leukemia (AML) With a Precision Genomic
Strategy to Assess Mutation Clearance
Lead Researcher: Eric Huselton
The investigators will prospectively determine whether the relapse-free and overall
survival in patients who have cleared their leukemia-associated mutations treated
with standard consolidation chemotherapy is superior to what is expected based on
historical controls. The investigators will also prospectively determine the relapse-free
and overall survival of patients who have not cleared their mutations. Because the
relapse rate of patients with persistent mutations is expected to be high, treatment
with either standard of care consolidation therapy alone or alloSCT will be permitted,
at the discretion of the treating physician.
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: Richard Dunne
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
Infant Allergy Study
Lead Researcher: Kirsi Jarvinen-seppo
The purpose of this study is to provide new knowledge about the development of infant
immunity, and set the groundwork for future studies in the prevention of allergic
diseases in childhood. We can study the difference between populations with allergic
diseases and those without allergic diseases by comparing breast milk, saliva, blood,
skin swab, nasal swab, urine, and stool samples.
Eligibility:
You need to be 18 years or older, healthy, and pregnant.
If you have allergies, such as hay fever, asthma, eczema, or food allergies in the
family (you, your partner, or another child), then you may qualify for this study.
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)
Lead Researcher: Angela Girvin
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 (ALL): Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone,
and Blinatumomab in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic
Leukemia (ALL)
Lead Researcher: Kristen O'Dwyer
This study will have 2 groups: subjects who do not have the Philadelphia chromosome
mutation (Ph-) and subjects who do have the mutation (Ph+). Treatments for the two
groups will be different and are outlined below.
In general, there are 3 main steps to all of the treatments. Induction/Re-Induction
treatment is given first. It is a treatment given over a short period of time (usually
only a few months) to get rid of as many of the leukemia cells as possible very quickly.
Post-Remission treatment is given next. It is given to get rid of any leukemia cells
that are left once your leukemia goes into remission and to make sure the leukemia
cells don’t come back over a short period of time (usually only a few months). Maintenance
treatment is given last. It is a lower dose treatment given over a long period of
time (up to several years) to help keep the leukemia cells from coming back.
Depending on which arm of the study you are on, Blinatumomab will be given as part
of induction/re-induction or post-remission along with standard chemotherapy.
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
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: 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: First-Line Treatment of M7824 Versus Pembrolizumab
Lead Researcher: Deborah Mulford
The study will evaluate M7824 monotherapy versus pembrolizumab as first-line treatment
for participants with advanced non-small-cell lung carcinoma (NSCLC) with high PD-L1-tumor
expression (PD-L1 stand for Programmed Death-Ligand 1).
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 (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 (iNHL): A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's
Lymphoma (ILyAD)
Lead Researcher: Jonathan Friedberg
If you decide and are eligible to take part in this study, in addition to the standard
treatment, rituximab, you will be randomized to receive an oral dose of either 2,000
IU vitamin D (also called cholecalciferol) supplementation or placebo. The randomization
will be 2:1. A 2:1 randomization means for every three people enrolled on the study,
two
people will receive vitamin D and one person will receive placebo. This study is conducted
in a double blind fashion, which means neither you nor your doctor will know which
treatment group you are in.
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: 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
Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation
Therapy in Treating Patients With Newly Diagnosed Ependymoma
Lead Researcher: Angela Girvin
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
Management of Tobacco Treatment Intervention in Reducing Surgical Complications in
Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Lead Researcher: Michal Lada
This randomized phase III trial studies how well management of a tobacco treatment
intervention works in reducing surgical complications in patients with newly diagnosed
lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares
varenicline (a drug that reduces the craving and withdrawal symptoms that occur with
abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered
intervention and tobacco quitline [tobacco cessation service available through a toll-free
telephone number] follow-up) with placebo (a pill with no active medication) along
with similar behavioral interventions. It is not yet known whether management of a
tobacco treatment intervention is more effective in reducing surgical complications
than placebo.
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
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
MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer
Lead Researcher: Marcus Noel
This study is designed to characterize the safety, tolerability, pharmacokinetics,
pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of MGD007 and
MGA012, administered in combination by IV infusion, in patients with relapsed/refractory
metastatic colorectal carcinoma.
The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose
(MTD) or Maximum Administered Dose (MAD) - MAD; if no MTD is defined - of the drug
combination, followed by a Cohort Expansion Phase to further define the safety and
initial anti-tumor activity of the drug combination with the doses established in
the Dose Escalation Phase.
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
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 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 or Lymphoma: Study of CLR 131 in Relapsed or Refractory Select B-Cell
Malignancies
Lead Researcher: Brea Lipe
This research is being done to help us determine if the study drug is safe and can
be tolerated for the treatment of multiple myeloma or certain lymphomas.
View Study Details
Multiple Myeloma: A Study of C-220 as a Single Treatment and in Combination with Other
Treatments
Lead Researcher: Brea Lipe
This is a multicenter, multi-country study consisting of two parts: Part 1) Evaluation
of dosing amounts of CC-220 alone, CC-220 in combination with DEX, CC-220 in combination
with DEX and DARA, CC-220 in combination with DEX and BTZ, and CC-220 in combination
with DEX and CFZ; Part 2) Expansion of the highest tolerated doses of CC-220 alone,
CC-220 in combination with DEX (DoubleT) for Relapsed Refractory Multiple Myeloma
and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
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
Multiple Myeloma: Integrating Touchscreen-based Geriatric Assessment and Frailty Screening
for Adults with Multiple Myeloma to Drive Personalized Treatment Decisions
Lead Researcher: Supriya Mohile
If you enter the study, you will be asked to complete an electronic questionnaire
on a sponsor- provided electronic tablet during an already scheduled clinical visit
to your medical oncology doctor’s office. The questionnaire will take about 10 minutes
to complete; study staff will remain available to assist you.
View Study Details
Multiple Myeloma: Selinexor and Backbone Treatments of Multiple Myeloma Patients (STOMP)
Lead Researcher: Brea Lipe
This is an open-label study, which means that both you and your study doctor will
know how much selinexor and the names of other medications you are taking. You, and
all other patients in this study, will take the study drug selinexor, plus dexamethasone
and either pomalidomide, bortezomib, lenalidomide, or daratumumab. The treatment period
consists of blocks of time called cycles. The number of treatment cycles you receive
will depend on how well you are doing on the treatment and how well your cancer responds
to it.
This study includes four different treatment combinations:
• Selinexor, dexamethasone and pomalidomide (abbreviated as SPd)
• Selinexor, dexamethasone and bortezomib (abbreviated as SVd)
• Selinexor, dexamethasone and lenalidomide (abbreviated as SRd)
• Selinexor, dexamethasone, daratumumab (abbreviated SDd)
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
Nab-Paclitaxel in Treating Patients With Newly Diagnosed Bile Tract Cancer
Lead Researcher: Aram Hezel
This phase III trial studies how well gemcitabine hydrochloride and cisplatin - given
with or without nab-paclitaxel - work in treating patients with newly diagnosed biliary
tract cancers that have spread to other places in the body. Drugs used in chemotherapy,
such as gemcitabine hydrochloride, cisplatin, and nab-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 known if giving gemcitabine
hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating
biliary tract cancers.
View Study Details
Neuropsychological and Behavioral Testing in Younger Patients With Cancer
Lead Researcher: Angela Girvin
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
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
Non-Hodgkin Lymphoma: Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy
Lead Researcher: Patrick Reagan
This is a Phase 2, open-label, multicenter study to determine the efficacy and safety
of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or
are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin
lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on
age, performance status, and/or comorbidities). Subjects will receive treatment with
lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics
and biomarkers, disease status, quality of life, and survival.
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
Observational Study of ICU Patients with Systemic Inflammatory Response Syndrome (SIRS)
Lead Researcher: Anthony Pietropaoli
An observational research study of subjects admitted to the ICU with severe SIRS (and/or
sepsis). For ICU subjects enrolled, the study involves blood and urine testing and
research measurements of blood flow using ultrasound.
At selected time points, healthy subjects will also be recruited as needed for collection
of healthy blood samples for comparison studies.
View Study Details
Olaparib and Cediranib Maleate in Treating Patients With Recurrent, Refractory, or
Metastatic Endometrial Cancer
Lead Researcher: Richard Moore
This phase II trial studies how well olaparib and cediranib maleate work in treating
patients with endometrial cancer that has come back (recurrent), does not respond
to treatment (refractory), or has spread to other places in the body (metastatic).
Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some
of the enzymes needed for cell growth.
View Study Details
Omega-3 Replacement With Krill Oil in Disease Management of SLE
Lead Researcher: Jennifer Anolik
A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031
or
placebo for 24 weeks (randomized period) and followed by an open label extension (OLE)
treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable
doses
of background medications, except for glucocorticoids. Decreases in doses of glucocorticoids
will be encouraged during the first 20 weeks of both the randomized and open label
extension
portions of the trial. Stable doses of glucocorticoids and other background medications
are
required during weeks 20-22 and 44-48. If indicated by the PI, brief increases in
corticosteroids are permitted during the first 20 weeks of both the blinded and open
label
extension portion of the trial. The increase in prednisone (or equivalent) dose is
limited to
2X the back-ground level to a maximum of 20 mg/day for a maximum of 1 week (7 days)
or to a
single administration of intravenous methylprednisolone or equivalent at a maximum
dose of
500mg. Stable doses of glucocorticoids and other background medications are required
during
weeks 20-22 and 44-48
View Study Details
Oropharyngeal Cancer Treatment: Reduced Dose Radiation Therapy with Chemotherapy (Cisplatin)
or Immunotherapy (Nivolumab)
Lead Researcher: Ronald Maggiore
This phase II/III trial studies how well a reduced dose of radiation therapy works
with nivolumab compared to cisplatin in treating patients with human papillomavirus
(HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread
to other parts of the body (early-stage), and is not associated with smoking.
Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs
used in chemotherapy, such as 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. Immunotherapy with monoclonal antibodies, such as nivolumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of tumor cells to grow and spread. This trial is being done to see if a reduced dose
of radiation therapy and nivolumab works as well as standard dose radiation therapy
and cisplatin in treating patients with oropharyngeal cancer.
View Study Details
Outcome Disparities in Adolescents with Acute Lymphoclastic Leukemia (ALL)
Lead Researcher: Kristen O'Dwyer
We will establish two prospective groups of patients with Acute Lymphoclastic Leukemia
(ALL):
"Cohort A" will be enrolled on the study at the time of diagnosis while "Cohort B"
will be enrolled during maintenance chemotherapy.
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: 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: 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
Paclitaxel, Trastuzumab, and Pertuzumab With or Without Atezolizumab in Treating Patients
With Metastatic Breast Cancer
Lead Researcher: Ajay Dhakal
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab
with or without atezolizumab works in treating patients with breast cancer that has
spread to other parts of the body. Drugs used in chemotherapy, such as 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. Immunotherapy
with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune
system and may interfere with the ability of tumor cells to grow and spread. It is
not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without
atezolizumab may kill more tumor cells.
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)
Lead Researcher: Angela Girvin
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: Addition of Eryaspase to Chemotherapy Versus Chemotherapy Alone
Lead Researcher: Aram Hezel
The drug, Eryaspase, is made of L-asparaginase placed inside donor-derived red blood
cells. It is designed to target the modified asparagine and glutamine metabolism of
cancer cells. This is an open-label, multicenter, randomized, Phase 3 study in patients
with ductal adenocarcinoma of the pancreas (pancreatic cancer) who have failed only
one prior line of anti-cancer therapy.
View Study Details
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Lead Researcher: Mohamedtaki Tejani
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in
combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen]
or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination
with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth
factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult
participants.
The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior
to placebo plus chemotherapy in terms of overall survival (OS), and progression-free
survival (PFS).
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
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
Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive
Breast Cancer (POSITIVE)
Lead Researcher: Alissa Huston
The best available evidence suggests that pregnancy after breast cancer does not increase
a woman's risk of developing a recurrence from her breast cancer. In particular, the
most recent data suggest that this is the case also in women with a hormone receptor-positive
breast cancer. There is also no indication of increased risk for delivery complications
or for the newborn. The aim of the study is to investigate if temporary interruption
of endocrine therapy, with the goal to permit pregnancy, is associated with a higher
risk of breast cancer recurrence.The study aims also to evaluate different specific
indicators related to fertility, pregnancy and breast cancer biology in young women.
A psycho-oncological companion study on fertility concerns, psychological well-being
and decisional conflicts will be conducted in interested Centers.
View Study Details
Project: Every Child for Younger Patients With Cancer
Lead Researcher: Angela Girvin
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
PROMISE - For Pregnant Women
Lead Researcher: Sheree Toth
Project PROMISE was developed for pregnant women and their babies once they are born.
The program provides families with services designed to improve family health and
functioning. These services include supports designed to improve familial relationships,
one-on-one support if feeling stressed, overwhelmed, or down, and providing information
about child development.
Inclusion Criteria: Participants will be low-income, pregnant, adult women eligible
for Medicaid, WIC, SNAP, or TANF.
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: Chunkit Fung
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: Chunkit Fung
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
QUILT-3.055: A Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor
in Patients With Advanced Cancer
Lead Researcher: Deborah Mulford
This is a Phase IIb, single-arm, multicohort, open-label multicenter study of ALT-803
in combination with an FDA-approved PD-1/PD-L1 checkpoint inhibitor in patients with
advanced cancers who have progressed following an initial response to treatment with
PD-1/PD-L1 checkpoint inhibitor therapy. All patients will receive the combination
treatment of PD-1/PD-L1 checkpoint inhibitor plus ALT-803 for up to 16 cycles. Each
cycle is six weeks in duration. All patients will receive ALT-803 once every 3 weeks.
Patients will also receive the same checkpoint inhibitor that they received during
their previous therapy. Radiologic evaluation will occur at the end of each treatment
cycle. Treatment will continue for up to 2 years, or until the patient experiences
confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the
Investigator feels it is no longer in the patient's best interest to continue treatment.
Patients will be followed for disease progression, post-therapies, and survival through
24 months past administration of the first dose of study drug.
View Study Details
Radiation Therapy and Cisplatin With or Without Triapine in Treating Patients With
Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal
Cancer
Lead Researcher: Richard Moore
This randomized phase III trial studies radiation therapy and cisplatin with triapine
to see how well they work compared to the standard radiation therapy and cisplatin
alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical
cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons
to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as 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. Triapine 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 and cisplatin are more effective with
triapine in treating cervical or vaginal cancer.
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
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Head and
Neck Cancer
Lead Researcher: Yuhchyau Chen
This randomized phase II/III trial studies how well radiation therapy works with durvalumab
or cetuximab in treating patients with head and neck cancer that has spread to a local
and/or regional area of the body who cannot take cisplatin. Radiation therapy uses
high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal
antibodies, such as durvalumab or cetuximab, may help the body's immune system attack
the cancer, and may interfere with the ability of tumor cells to grow and spread.
It is not known if radiation therapy with durvalumab will work better than the usual
therapy of radiation therapy with cetuximab in treating patients with head and neck
cancer.
View Study Details
Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage
IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)
Lead Researcher: Megan Baumgart
This phase II Lung-MAP non-Match treatment trial studies how well ramucirumab and
pembrolizumab work versus standard of care in treating patients with non-small cell
lung cancer that is stage IV or has come back. Immunotherapy with monoclonal antibodies,
such as ramucirumab and pembrolizumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs
used in standard of care chemotherapy for non-small cell lung cancer, such as docetaxel,
gemcitabine hydrochloride, and pemetrexed, 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 ramucirumab and pembrolizumab together may work
better in treating patients with non-small lung cancer compared to standard of care.
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: Aram Hezel
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
Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients
With Newly Diagnosed WNT-Driven Medulloblastoma
Lead Researcher: Angela Girvin
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
Registry of Full-genome Data Linked with Clinical Data to Evaluate New Gene Associations
in Breast Cancer
Lead Researcher: Ajay Dhakal
The purpose of this registry is to create a large-scale, population-based database.
This
database will match health information to genome data to identify new gene associations
in
breast cancer. The study will look at Agendia Breast Cancer tests, including MammaPrint®
and BluePrint™, which
are tests that help doctors analyze and profile breast cancer tumors.
View Study Details
Related-Donor Bone Marrow Transplant at URMC
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 stem cell
transplantation 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.
View Study Details
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients
With Non-high Risk Neuroblastoma
Lead Researcher: Angela Girvin
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
Lead Researcher: Angela Girvin
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
Rituximab in Treating Patients With Mantle Cell Lymphoma
Lead Researcher: Paul Barr
This randomized phase III trial studies rituximab after stem cell transplant and to
see how well it works compared with rituximab alone in treating patients with in minimal
residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal
antibodies, such as rituximab, may interfere with the ability of cancer cells to grow
and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer
cells that are in the body and helps make room in the patient's bone marrow for new
blood-forming cells (stem cells) to grow. After treatment, stem cells are collected
from the patient's blood and stored. More chemotherapy is then given to prepare the
bone marrow for the stem cell transplant. The stem cells are then returned to the
patient to replace the blood-forming cells that were destroyed by the chemotherapy.
Giving rituximab with or without stem cell transplant may work better in treating
patients with mantle cell lymphoma.
View Study Details
Ruxolitinib Phosphate and Dasatinib or Nilotinib in Treating Patients With Chronic
Myeloid Leukemia
Lead Researcher: Kristen O'Dwyer
This randomized phase II trial studies how well ruxolitinib phosphate and dasatinib
or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib,
dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth.
View Study Details
Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage
III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Lead Researcher: Richard Moore
This phase I/II partially randomized trial studies the side effects and the best dose
of ruxolitinib phosphate when given together with paclitaxel and carboplatin, and
it will look at how well these drugs work in treating patients with stage III-IV epithelial
ovarian, fallopian tube, or primary peritoneal cancer. Ruxolitinib phosphate may stop
the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as paclitaxel 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. Giving ruxolitinib phosphate together
with paclitaxel and carboplatin may be a better treatment for epithelial ovarian,
fallopian tube, or primary peritoneal cancer.
View Study Details
Safety and Efficacy of KTE-X19 in Adults With Relapsed/Refractory Chronic Lymphocytic
Leukemia (ZUMA-8)
Lead Researcher: Patrick Reagan
Participants will receive conditioning chemotherapy (fludarabine and cyclophosphamide),
followed by the investigational treatment, KTE-X19. KTE-X19 is a CAR-T Cell Therapy
(infusion).
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
Saltwater Tasting Study
Lead Researcher: Paul Geha
This research study includes 2 study sessions. During both sessions, participants
will taste and rate different solutions of salt and water. The first session is to
train participants on how to report subjective taste experience and to ensure comfort
with having a functional Magnetic Resonance Imaging (fMRI) scan. The second session
will take place on a separate day, and participants will be asked to report subjective
taste experience - this time in the MRI scanner. Eligibility: Ages 18-45, non-smoker,
healthy
View Study Details
Screening Patients for Breast Cancer with Advanced 3-D Breast Imaging
Lead Researcher: Avice O'Connell
This phase III trial is looking at an advanced 3-D imaging technique, digital tomosynthesis
mammography, to screen patients for breast cancer. It uses a low-dose x-ray system
and computer reconstructions to create three-dimensional images of the breasts.
This method of screening may be superior to digital mammography for breast cancer
screening and may help reduce the need for additional imaging or treatment.
Eligibility: Women of childbearing potential (must not be known to be pregnant or
lactating). Must be scheduled for, or have intent to schedule, a screening mammogram.
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)
Lead Researcher: Angela Girvin
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
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
Stage II-IV Ovarian or Primary Peritoneal Cancer: Treatment with Letrozole with or
without Paclitaxel and Carboplatin
Lead Researcher: Richard Moore
This phase III trial studies how well letrozole with or without paclitaxel and carboplatin
works in treating patients with stage II-IV low-grade serous carcinoma of the ovary
or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen
made by the body which in turn may stop the growth of tumor cells that need estrogen
to grow. Drugs used in chemotherapy, such as paclitaxel 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. It is not yet known whether giving
letrozole alone or in combination with paclitaxel and carboplatin works better in
treating patients with low-grade serous carcinoma of the ovary or peritoneum compared
to paclitaxel and carboplatin without letrozole.
View Study Details
Stage IV Lung Cancer: First-Line Immunotherapy Alone or in Combination with Chemotherapy
Lead Researcher: Deborah Mulford
This phase III trial studies whether pembrolizumab alone as a first-line treatment,
followed by pemetrexed and carboplatin with or without pembrolizumab after disease
progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin
followed by pembrolizumab and pemetrexed maintenance in treating patients with stage
IV non-squamous non-small cell lung cancer.
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. Drugs used in chemotherapy, such as pemetrexed 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. It is not yet
known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin
with or without pembrolizumab works better in treating patients with non-squamous
non-small cell cancer.
View Study Details
Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery
in Treating Patients With Limited Metastatic Breast Cancer
Lead Researcher: Yuhchyau Chen
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
Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage
Breast Cancer
Lead Researcher: Kristin Skinner
This randomized phase III trial studies standard or comprehensive radiation therapy
in treating patients with early-stage breast cancer who have undergone surgery. Radiation
therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive
radiation therapy is more effective than standard radiation therapy in treating patients
with breast cancer.
View Study Details
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants
With Metastatic Prostate Cancer
Lead Researcher: Chunkit Fung
This phase III trial studies how well standard systemic therapy with or without definitive
treatment (prostate removal surgery or radiation therapy) works in treating participants
with prostate cancer that has spread to other places in the body. Addition of prostate
removal surgery or radiation therapy to standard systemic therapy for prostate cancer
may lower the chance of the cancer growing or spreading.
View Study Details
Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer
Lead Researcher: Deepinder Singh
This study's goal is to find out if the kind of side effects people experience from
radiation is different depending on the schedule of their radiation treatment. Patients
will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation.
After patients complete radiation treatment, they will follow up with their radiation
oncologist.
View Study Details
Study Evaluating KTE-X19 in Pediatric and Adolescent Participants With Relapsed/Refractory
B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin
Lymphoma
Lead Researcher: Kristen O'Dwyer
This study will determine if the drug KTE-X19 is safe and effective in treating in
pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute
lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma
(NHL).
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 Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab
Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial
Cancer (NILE)
Lead Researcher: Chunkit Fung
This is a randomized, open-label, controlled, multi-center, global Phase III study
to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard
of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet)
followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in
patients with histologically or cytologically documented, unresectable, locally advanced
or metastatic transitional cell carcinoma of the urothelium (including renal pelvis,
ureters, urinary bladder, and urethra).
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 Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant
Prostate Cancer
Lead Researcher: Eric Huselton
This study will determine if the drugs olaprib and abiraterone are safe, well-tolerated
and effective in treating metastatic castration-resistant prostate cancer. Metastatic
castration-resistant prostate cancer is when the cancer has spread to parts of the
body other than the prostate, and it is able to grow and spread even though drugs
or other treatments to lower the amount of male sex hormones are being used to manage
the cancer. Patients cannot have received prior chemotherapy or new hormonal agents
metastatic castration-resistant prostate cancer.
Approximately 720 patients globally will be randomized to treatment with either olaparib
and abiraterone or placebo and abiraterone.
View Study Details
Study of PTC299 in Relapsed/Refractory Acute Leukemias
Lead Researcher: Michael Becker
This is an open-label, non-randomized, Phase 1b study to evaluate the safety, pharmacokinetics
(PK) profiles, and preliminary evidence of antitumor activity of PTC299 and the metabolite,
O-desmethyl PTC299, in participants with relapsed/refractory acute myeloid leukemia
(AML) who have exhausted standard available therapies known to provide clinical benefit.
The study is designed as a series of cohort-based dose escalations. For each cohort,
a minimum of 3 evaluable participants with PK and safety data will be assessed. Additional
participants will be recruited if additional PK data are needed to assess mean exposure
based on the observed variability.
View Study Details
Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
Lead Researcher: Aram Hezel
This is an open-label phase 1A/1B study to assess the safety, tolerability, and movement
throughout the body (pharmacokinetics) of SBP-101 when combined with nab-paclitaxel
and gemcitabine in patients with previously untreated pancreatic cancer (metastatic
pancreatic ductal adenocarcinoma) and to identify a recommended phase 2 dose. The
study will also assess preliminary efficacy of the 3-drug treatment combination.
View Study Details
Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
Lead Researcher: Alan Katz
The purpose of this study is to determine if a short course of radiation therapy is
effective to treat rectal cancer in older patients. A shorter course of radiation
treatment may be better tolerated than a longer course or surgery for the treatment
of rectal cancer in the elderly. Inclusion Criteria: Diagnosis of rectal cancer; 70
years or older at time of diagnosis
View Study Details
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant
Prostate Cancer
Lead Researcher: Chunkit Fung
The purpose of this study is to evaluate the efficacy and safety (including evaluating
side effects) of combination of olaparib and abiraterone versus placebo and abiraterone
in patients with metastatic castration-resistant prostate cancer (mCRPC) who have
received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic
castration-resistant prostate cancer (mCRPC) stage.
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
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.
View Study Details
Talk Therapy by Phone to Promote Treatment for Alcohol Problems
Lead Researcher: Kenneth Conner
A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related
care despite research showing that treatment is effective. This randomized controlled
trial tests the efficacy of a brief, phone based cognitive behavioral intervention
to increase treatment engagement, improve alcohol related outcomes, and show that
treatment engagement is a mechanism for the improved outcomes in individuals with
AUD. This study will also asses the impact of COVID-19 on alcohol use and other quality
of life measures.
View Study Details
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)
Lead Researcher: Angela Girvin
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.
View Study Details
Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A
LUNG-MAP Treatment Trial)
Lead Researcher: Megan Baumgart
This phase II LUNG-MAP treatment trial studies how well selpercatinib works in treating
patients with RET fusion-positive non-small cell lung cancer that is stage IV or has
come back (recurrent). Selpercatinib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth.
View Study Details
Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial
Cancer
Lead Researcher: Richard Moore
This phase II trial studies how well tazemetostat works in treating patients with
ovarian, primary peritoneal, or endometrial cancer that has come back. Drugs used
in chemotherapy, such as tazemetostat, 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
Testing Maintenance Immunotherapy in Patients With Oropharynx Cancer
Lead Researcher: Ronald Maggiore
This phase II/III trial studies whether maintenance immunotherapy (nivolumab) following
definitive treatment with radiation and chemotherapy (cisplatin) result in significant
improvement in overall survival (time being alive) and progression-free survival (time
being alive without cancer) for patients with intermediate risk human papillomavirus
(HPV) positive oropharynx cancer that has spread to nearby tissue or lymph nodes.
Drugs used in chemotherapy such as 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. Radiation therapy uses high energy rays to kill tumor
cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation
therapy followed by maintenance nivolumab therapy works better than chemotherapy and
radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.
View Study Details
Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy
for High Grade B-cell Lymphomas
Lead Researcher: Patrick Reagan
This phase II/III trial tests whether it is possible to decrease the chance of high-grade
B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the
usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer
cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as
rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide,
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 venetoclax
together with usual chemotherapy may work better than usual chemotherapy alone in
treating patients with high-grade B-cell lymphomas, and may increase the chance of
cancer going into remission and not returning.
View Study Details
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy
Treatment (Paclitaxel and Carboplatin) in Stage III-IV Uterine Cancer
Lead Researcher: Richard Moore
This phase III trial studies how well the combination of pembrolizumab, paclitaxel,
and carboplatin, works compared with paclitaxel and carboplatin alone in treating
patients with endometrial cancer that is stage III, IV, or has come back (recurrent).
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part
of the usual treatment approach for this type of cancer. This study aims to assess
if adding immunotherapy to these drugs is better or worse than the usual approach
for treatment of this cancer.
View Study Details
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With
One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Lead Researcher: Adrienne Victor
This phase II trial studies how well cabozantinib works in combination with nivolumab
and ipilimumab in treating patients with rare genitourinary (GU) tumors that have
spread to other places in the body. Cabozantinib may stop the growth of tumor cells
by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal
antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack
the cancer, and may interfere with the ability of tumor cells to grow and spread.
Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients
with genitourinary tumors that have no treatment options compared to giving cabozantinib,
nivolumab, or ipilimumab alone.
View Study Details
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children,
Adolescents, and Young Adults With B-acute lymphoblastic leukemia (ALL)
Lead Researcher: Jeffrey Andolina
This study will evaluate the use of non- TBI (total body irradiation) conditioning
for B-ALL patients with low risk of relapse as defined by the lack of residual disease
(NGS-MRD before receiving a hematopoietic cell transplant (HCT). Patients diagnosed
with B-ALL who are candidates for a transplant will be screened on a test of bone
marrow done before the transplant.
View Study Details
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.
A $50 prepaid Visa gift card will be provided for taking part in this study (one per
family).
View Study Details
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.
View Study Details
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.
View Study Details
Treating Head and Neck Cancer or Prostate Cancer with Combination Drugs: Avelumab
+ Bempegaldesleukin
Lead Researcher: Ronald Maggiore
This study will test the combination of drugs, avelumab + bempegaldesleukin (NKTR-214
), in treating locally advanced skin cancer of the head and neck (metastatic squamous
cell carcinoma). It will also look at avelumab + bempegaldesleukin (NKTR-214) + either
talazoparib or enzalutamide in metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria:
•Participants must be ≥ 18 years old.
•Participants with squamous cell carcinoma of the head or neck or mCRPC.
View Study Details
Treatment of Opioid Withdrawal
Lead Researcher: John Markman
Eligible subjects will begin a planned, 14-day taper of their opioid medication and
will be randomly assigned to receive the study drug, either LUCEMYRA or a placebo
tablet. LUCEMYRA is currently approved for abrupt discontinuation of opioids. You
may be eligible if you are 18 yrs or older, on oral opioid dosage of 50-240 MME daily
for at least 12 wks, have chronic non-cancer pain for at least 6 mos, and have no
cardiovascular abnormalities.
View Study Details
Umbilical Cord Blood Transplantation From Unrelated Donors
Lead Researcher: Omar Aljitawi
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
prevention drugs for graft versus host disease.
Multiple data points will be collected prior to, during, and following transplantation
to ensure safety of the process and to evaluate the stated objectives.
View Study Details
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.
View Study Details
Ustekinumab for Primary Sjogren's Syndrome
Lead Researcher: Ummara Shah
Ustekinumab is FDA approved for treatment of Psoriasis, Psoriatic Arthritis, and Crohn's
disease, but it has not been previously used in the treatment of Primary Sjogren's
Syndrome. Participants will complete 6 study visits over the course of 6 months. Subjects
will receive an infusion of ustekinumab at the second visit and an injection of ustekinumab
at the next 3 visits. Subjects will have assessments of their health at all visits.
View Study Details
Uterine Cancer Treatment: Lenvatinib in Combination With Pembrolizumab Versus Physician's
Choice
Lead Researcher: Richard Moore
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib
(E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the
treatment of advanced endometrial (uterine) cancer. Participants will be randomly
assigned to receive either pembrolizumab and lenvatinib or treatment of physician's
choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib
prolongs progression free survival (PFS) and overall survival (OS) when compared to
treatment of physician's choice.
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.
View Study Details
WATCH-PD: Sensor-Based Measurements of Parkinson's Disease
Lead Researcher: Jamie Adams
WATCH-PD is a study conducted by the Parkinson Study Group (PSG) to learn more about
early Parkinson disease (PD). The study takes place over a 12 month period and includes
7 in-person visits, 2 brain scans, and 3 phone calls. If you complete all visits,
you will receive up to $1000 as well as an Apple Watch and an iPhone to keep.
At in-person study visits, doctors will rate various aspects of your Parkinson’s disease,
you’ll fill out surveys about your quality of life, and you’ll perform motor and cognitive
tasks with various sensor systems. We’ll also ask you to wear your Apple Watch at
home and periodically complete motor and cognitive assessments.
The two brain scans (DaTscan) will take place at the beginning and end of the study.
A DaTscan involves a small amount of radiation. The level of radiation exposure is
similar to other common procedures, such as an x-ray. (similar exposure to radiation
as other common procedures, such as an x-ray).
By comparing standard PD health assessments in the clinic to digital measures obtained
on mobile devices, we hope to better understand PD. Future use of this technology
may help shorten the duration of clinical trials and require fewer participants. Moreover,
people diagnosed with PD in the future might benefit from what we learn by your participation.
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.
View Study Details
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.
View Study Details
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