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.
4AP/ UGUP18139/ Ahmed Ghazi
Lead Researcher: Ahmed Ghazi
To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral
nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine
speeds the often slow and unpredictable recovery after peripheral nerve traction and/or
crush injuries.
View Study Details
A Pilot Study to Assess the Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
Lead Researcher: James Aquavella
The objective of this study is to collect preliminary efficacy and safety data on
the use of EDTA EYE Drops (EED) on subjects during an episode of band keratopathy
(BK).
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 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 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 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
A041703 / CLEU19006 / O'Dwyer, Kristen
Lead Researcher: Kristen O'Dwyer
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in
treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is
newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with
monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the
body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread.
View Study Details
ALCHEMIST A151216 Screening Protocol
Lead Researcher: Yuhchyau Chen
This 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
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
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
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
Baby formula and health
Lead Researcher: Bridget Young
Participation in this study involves one visit that will last for about four hours
at your home or the Strong Memorial Hospital Clinical Research Center. Procedures
include infant glucose test, timed infant urine collection, infant heel pricks, and
infant body size measurements.
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: 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
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
CBMT11074 / NMDP 10-CBA / Jane Liesveld
Lead Researcher: Jane Liesveld
This study is an access and distribution protocol for unlicensed cryopreserved cord
blood units (CBUs) in pediatric and adult patients with hematologic malignancies and
other indications.
View Study Details
CBMT17006 / A051301 / Michael Becker
Lead Researcher: Michael Becker
This randomized phase III trial studies ibrutinib to see how well it works compared
to placebo when given before and after stem cell transplant in treating patients with
diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed)
or does not respond to treatment (refractory). Before transplant, stem cells are taken
from patients and stored. Patients then receive high doses of chemotherapy to kill
cancer cells and make room for healthy cells. After treatment, the stem cells are
then returned to the patient to replace the blood-forming cells that were destroyed
by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells
by blocking a protein that is needed for cell growth. It is not yet known whether
adding ibrutinib to chemotherapy before and after stem cell transplant may help the
transplant work better in patients with relapsed or refractory diffuse large B-cell
lymphoma.
View Study Details
CBRS17061 / EA1131 / Michelle Shayne
Lead Researcher: Michelle Shayne
This randomized phase III trial studies how well cisplatin or carboplatin (platinum
based chemotherapy) works compared to capecitabine in treating patients with remaining
(residual) basal-like triple-negative breast cancer following chemotherapy after surgery
(neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine,
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 cisplatin or carboplatin is more effective than capecitabine in treating
patients with residual triple negative basal-like breast cancer.
View Study Details
CBRS18089 / S1418 / Alissa Huston
Lead Researcher: Alissa Huston
This randomized phase III trial studies how well pembrolizumab works in treating patients
with triple-negative breast 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.
View Study Details
CBRS18119 / S1706 / Ajay Dhakal
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
CBRS19033 / TMIST / Avice O'Connell
Lead Researcher: Avice O'Connell
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for additional imaging or treatment.
View Study Details
CBRS19055 / NRG-BR004 / Ajay Dhakal
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 (metastatic). 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
is a form of "targeted therapy" because it works by attaching itself to specific molecules
(receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab
attaches to HER2 receptors, the signals that tell the cells to grow are blocked and
the cancer cell may be marked for destruction by the body's immune system. Monoclonal
antibodies, such as pertuzumab, may interfere with the ability of cancer cells to
grow and spread. Immunotherapy with monoclonal antibodies, such as 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
CBRS19096 / A221702 / Kristin Skinner
Lead Researcher: Kristin Skinner
This phase III trial studies how well axillary reverse mapping works in preventing
lymphedema in patients with breast cancer undergoing axillary lymph node dissection.
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
CBRS20023, Dhakal, EA1181, Breast Cancer, Paclitaxel Docetaxel Trastuzumab Pertuzumab
Nab-paclitaxel
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
CBRS20072 / A011202 / Skinner
Lead Researcher: Kristin Skinner
This randomized phase III trial studies lymph node dissection and radiation therapy
to see how well it works compared to radiation therapy alone in treating patients
with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection
may remove cancer cells that have spread to nearby lymph nodes in patients with breast
cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells.
It is not yet known if radiation therapy works better alone or with lymph node dissection
in treating patients with breast cancer previously treated with chemotherapy and surgery.
View Study Details
CBRT19124/ ACNS1721 / Angela Girvin
Lead Researcher: Angela Girvin
This phase II trial studies how well veliparib, radiation therapy, and temozolomide
work in treating patients with newly diagnosed malignant glioma without H3 K27M or
BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are
proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep
PARP from working, so tumor cells can't repair themselves, and they may stop growing.
Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs
used in chemotherapy, such as temozolomide, work in different ways to stop the growth
of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Giving veliparib, radiation therapy, and temozolomide
may work better in treating patients with newly diagnosed malignant glioma without
H3 K27M or BRAFV600 mutations compared to radiation therapy and temozolomide alone.
View Study Details
CBRT20102 / NRG-BN007 / Andrea Wasilewski
Lead Researcher: Andrea Wasilewski
This phase II/III trial compares the usual treatment with radiation therapy and temozolomide
to radiation therapy plus immunotherapy with ipilimumab and nivolumab in treating
patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses
high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide,
work in different ways to stop the growth of tumor cells, either by killing the cells,
by stopping them from dividing, or by stopping them from spreading. Immunotherapy
with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. Giving radiation therapy with ipilimumab and nivolumab lengthen
the time without brain tumor from returning or growing and extend patients life compared
to usual treatment of radiation therapy and chemotherapy.
View Study Details
CGIH19111 / S1815 / Aram Hezel
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
CGIH20014, Dunne, EA2187, Cholangiocarcino, Pevonedistat, Carboplatin, Paclitaxel
Lead Researcher: Richard Dunne
This phase II trial studies how well pevonedistat alone or in combination with chemotherapy
(paclitaxel and carboplatin) works in treating patients with bile duct cancer of the
liver. Pevonedistat 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. This study may
help the study doctors find out how well pevonedistat shrinks bile duct cancer of
the liver when given alone and when in combination with paclitaxel and carboplatin.
View Study Details
CGIM20007, Hezel, S1922, Small Intestinal Adenocarcinoma, Fluorouracil, Irinotecan
Hydrochloride
Lead Researcher: Aram Hezel
This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen
(leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating
patients with small bowel cancers that have spread extensively to other anatomic sites
(advanced) or are no longer responding to treatment (refractory). Ramucirumab is a
monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This
may restrain new blood vessel formation therefore reducing nutrient supply to tumor
which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy,
such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride
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
plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small
bowel cancers and may help patients live longer.
View Study Details
CGIP19127 / A021602 / Aram Hezel
Lead Researcher: Aram Hezel
This randomized phase III trial studies cabozantinib to see how well it works compared
with placebo in treating patients with neuroendocrine or carcinoid tumors that have
spread to other places in the body (advanced). Cabozantinib 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
CGIP20076, Zittel, EA2186, 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan
Lead Researcher: Jason Zittel
This phase II trial compares two treatment combinations: gemcitabine hydrochloride
and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan
in older patients with pancreatic cancer that has spread to other places in the body
(metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel,
fluorouracil, leucovorin calcium, and liposomal irinotecan, 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. This study may help doctors find out
which treatment combination is better at prolonging life in older patients with metastatic
pancreatic cancer.
View Study Details
CGIP20087 / A021806 / Richard Dunne
Lead Researcher: Richard Dunne
This phase III trial compares perioperative chemotherapy (given before and after surgery)
versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic
cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs,
such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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 chemotherapy before and after
surgery (perioperatively) may work better in treating patients with pancreatic cancer
compared to giving chemotherapy after surgery (adjuvantly).
View Study Details
CGUB19067 / S1600 / Edward Messing
Lead Researcher: Edward Messing
This randomized phase III trial studies how well nutrition therapy works in improving
immune system in patients with bladder cancer that can be removed by surgery. Improving
nutrition before and after surgery may reduce the infections and other problems that
sometimes occur after surgery.
View Study Details
CGUK20101 / A031704 / Deepak Sahasrabudhe
Lead Researcher: Deepak Sahasrabudhe
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab
followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed
by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that
has spread to other parts of the body. The addition of cabozantinib to the usual treatment
may make it work better. 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. Chemotherapy drugs, such as cabozantinib,
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 how well the combination of cabozantinib and nivolumab after initial treatment
with ipilimumab and nivolumab works in treating patients with renal cell cancer that
has spread to other parts of the body.
View Study Details
CGUP18150 / S1802 / Chunkit Fung
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
CGYC16057 / NRG-GY006 / Richard Moore
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
CGYE19140 / NRG-GY018 / Richard Moore
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 or 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
CGYM19142 / NRG-GY019 / Richard Moore
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,
fallopian tube, 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, fallopian
tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
View Study Details
CGYO20085 / NRG-CC008 / Richard Moore
Lead Researcher: Richard Moore
This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral
salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with
BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian
tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the
fallopian tubes and ovaries. This study may help doctors determine if the two surgical
procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1
mutations.
View Study Details
CHAN17022 / EA3132 / Megan Baumgart
Lead Researcher: Megan Baumgart
This phase II trial studies how well radiation therapy with or without cisplatin works
in treating patients with stage III-IVA squamous cell carcinoma of the head and neck
who have undergone surgery. 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. It is not yet known if radiation
therapy is more effective with or without cisplatin in treating patients with squamous
cell carcinoma of the head and neck.
View Study Details
CHAN18065 / EA3163 / Megan Baumgart
Lead Researcher: Megan Baumgart
This randomized phase II trial studies how well chemotherapy before surgery and radiation
therapy works compared to surgery and radiation therapy alone in treating patients
with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in
chemotherapy, such as docetaxel, cisplatin, and carboplatin work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays
to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation
therapy may make the tumor smaller and reduce the amount of normal tissue that needs
to be removed and treated with radiation.
View Study Details
CHAN19107 / EA3161 / Megan Baumgart
Lead Researcher: Megan Baumgart
This phase II/III trials 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 (throat 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
CHAN19131 / NRG-HN005 / Megan Baumgart
Lead Researcher: Megan Baumgart
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. Chemotherapy
drugs, 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
CLEU18093 / A041501 / Kristen O'Dwyer
Lead Researcher: Kristen O'Dwyer
This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin
and how well it works when given with frontline chemotherapy in treating patients
with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as
inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain
cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better
in treating young adults with B acute lymphoblastic leukemia.
View Study Details
CLEU19025 / A041701 / Chemo + Uproleselan for AML / Jane Liesveld
Lead Researcher: Jane Liesveld
This phase II/III trial studies how well daunorubicin and cytarabine with or without
uproleselan works in treating older adult patients with acute myeloid leukemia receiving
intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin
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.
Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin
and cytarabine with uproleselan may work better in treating patients with acute myeloid
leukemia compared to daunorubicin and cytarabine alone.
View Study Details
CLEU20105/ S1905/ Kristen O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase II trial studies how well OBI-3424 works in treating patients with T-cell
acute lymphoblastic leukemia that has come back (relapsed) or does not response to
treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, 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. OBI-3424 may reduce the amount
of leukemia in the body.
View Study Details
CLEU20136 / EA9181 / O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase III trial compares the effect of usual treatment of chemotherapy and steroids
and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab
is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer
cells to grow and spread. The information gained from this study may help researchers
determine if combination therapy with steroids, TKIs, and blinatumomab work better
than the standard of care.
View Study Details
CLUN19026 / LUNGMAP / Megan Baumgart
Lead Researcher: Megan Baumgart
This screening and multi-sub-study randomized phase II/III trial will establish a
method for genomic screening of similar large cancer populations followed by assigning
and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP).
The type of cancer trait (biomarker) will determine to which sub-study, within this
protocol, a participant will be assigned to compare new targeted cancer therapy, designed
to block the growth and spread of cancer, or combinations to standard of care therapy
with the ultimate goal of being able to approve new targeted therapies in this setting.
In addition, the protocol includes non-match sub-studies which will include all screened
patients not eligible for any of the biomarker-driven sub-studies.
View Study Details
CLUN19153, Mulford, EA5163/S1709, NSCLC, Carboplatin, Pemetrexed
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
CLUN20016 / S1900B / Baumgart
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
CLUN20055 / EA5181 / Arpan Patel, MD
Lead Researcher: Arpan Patel
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and
radiation therapy (chemoradiation) works in treating patients with stage III non-small
cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with
monoclonal antibodies, such as durvalumab, may help the body's immune system attack
the cancer, and may interfere with the ability of tumor cells to grow and spread.
This study is being done to see if adding durvalumab to standard chemoradiation followed
by additional durvalumab can extend patients life and/or prevent the tumor from coming
back compared to the usual approach of chemoradiation alone followed by durvalumab.
View Study Details
CLYM17097 / S1608 / Paul Barr
Lead Researcher: Paul Barr
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide,
or combination chemotherapy work in treating patients with grade I-IIIa follicular
lymphoma that has come back (relapsed) or does not respond to treatment (refractory).
Immunotherapy with obinutuzumab, may induce changes in body's immune system and may
interfere with the ability of tumor cells to grow and spread. Umbralisib may stop
the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Biological therapies, such as lenalidomide, use substances made from living organisms
that may stimulate or suppress the immune system in different ways and stop cancer
cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin,
vincristine, prednisone, and bendamustine, work in different ways to stop the growth
of cancer cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. It is not yet known whether giving obinutuzumab with
or without umbralisib, lenalidomide, or combination chemotherapy will work better
in treating patients with grade I-IIIa follicular lymphoma.
View Study Details
CLYM17103 / EA4151 / Paul Barr
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
CLYM19112 / S1826 / Jonathan Friedberg
Lead Researcher: Jonathan Friedberg
This 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. Chemotherapy
drugs, 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
CLYM19123 / AALL1731 / Angela Girvin
Lead Researcher: Angela Girvin
This phase III trial studies how well blinatumomab works in combination with chemotherapy
in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia
or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies,
such as blinatumomab, may induce changes in the body's immune system and may interfere
with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such
as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate,
cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases
the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy
may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work
better than combination chemotherapy alone in treating patients with B-ALL. This trial
also assigns patients into different chemotherapy treatment regimens based on risk
(the chance of cancer returning after treatment). Treating patients with chemotherapy
based on risk may help doctors decide which patients can best benefit from which chemotherapy
treatment regimens.
View Study Details
CLYM19132 / A051701 / Patrick Reagan
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
CLYM19150 / EA4181 / Reagan
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 one 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
CMEL19154, Adrienne Victor, S1801, Melanoma, Pemrolizumab
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 compared to after surgery alone in treating
melanoma.
View Study Details
CMEL20008, Victor, EA6174, Merkel Cell Carcinoma, Pembrolizumab
Lead Researcher: Adrienne Victor
This phase III trial studies how well pembrolizumab works compared to standard of
care observation in treating patients with stage I-III Merkel cell cancer that has
been completely removed by surgery (resected). 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.
View Study Details
CMLT18023 / DART / Paul Barr
Lead Researcher: Paul Barr
This phase II trial studies nivolumab and ipilimumab in treating patients with rare
tumors. 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.
This trial enrolls participants for the following cohorts based on condition:
Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma
with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal,
nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN])
B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to
accrual 07/27/2018)
Epithelial tumors of major salivary glands (closed to accrual 03/20/2018)
Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and
lung, breast and other location (closed to accrual)
Undifferentiated carcinoma of gastrointestinal (GI) tract
Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018)
Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon,
rectum, pancreas) (closed to accrual 10/17/2018)
Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the
appendix and ovary (closed to accrual 03/20/2018)
Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma
or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible
Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018)
Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018)
Sarcomatoid carcinoma of lung
Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma
in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or
invasive mucinous adenocarcinoma
Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed
tumor and adenosarcoma (closed to accrual 03/30/2018)
Trophoblastic tumor: A) Choriocarcinoma (closed to accrual)
Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder
(closed to accrual)
Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular
sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation
(closed to accrual)
Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants
of penis
Squamous cell carcinoma variants of the genitourinary (GU) system
Spindle cell carcinoma of kidney, pelvis, ureter
Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual
07/27/2018)
Odontogenic malignant tumors
Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas
and digestive tract.) (closed to accrual)
Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017)
Pheochromocytoma, malignant (closed to accrual)
Paraganglioma (closed to accrual 11/29/2018)
Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex
(closed to accrual)
Desmoid tumors
Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018)
Malignant giant cell tumors
Chordoma (closed to accrual 11/29/2018)
Adrenal cortical tumors (closed to accrual 06/27/2018)
Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017)
Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the
NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019)
Adenoid cystic carcinoma (closed to accrual 02/06/2018)
Vulvar cancer (temporarily closed to accrual)
MetaPLASTIC carcinoma (of the breast) (closed to accrual)
Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018)
Perivascular epithelioid cell tumor (PEComa)
Apocrine tumors/extramammary Paget's disease (closed to accrual)
Peritoneal mesothelioma (temporarily closed to accrual 05/08/2020)
Basal cell carcinoma (temporarily closed to accrual 04/29/2020)
Clear cell cervical cancer
Esthenioneuroblastoma (closed to accrual)
Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual)
Clear cell ovarian cancer (closed to accrual)
Gestational trophoblastic disease (GTD)
Gallbladder cancer
Small cell carcinoma of the ovary, hypercalcemic type
PD-L1 amplified tumors
Angiosarcoma
High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should
be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into
Cohort 52). Small cell lung cancer is not eligible (temporarily closed to accrual
03/25/2020)
Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
View Study Details
CMLT20003, Moore, NRG-GY022, Malignant Solid Neoplasm, Carboplatin
Lead Researcher: Richard Moore
This trial studies how well iohexol works in helping doctors calculate the dose of
carboplatin given to patients with cancer. 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
CMLT20100 / S1823 / Chunkit Fung
Lead Researcher: Chunkit Fung
This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can
predict the chance of cancer returning in patients with germ cell cancers. Studying
samples of blood from patients with germ cell cancers in the laboratory may help doctors
predict how likely the cancer will come back.
View Study Details
CMMY19113 / S1803 / Brea Lipe
Lead Researcher: Brea Lipe
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to
Reg Step 2. Patients are followed until they will begin Maintenance and then registered
to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide
for 2 years and Lenalidomide + Daratumumab/rHuPH20. 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 further randomized (Reg Step
3) to either continue or discontinue the assigned treatment. Patients are treated
for up to 7 years from Step 2 reg and followed for up to 15 years.
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: 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
Comparing Healthy Young Adults/Children to Those With CLN3 Disease
Lead Researcher: Erika Augustine
We are inviting children and young adults with no known neurological disease to participate
in a research study that
involves brain magnetic resonance imaging (MRI) scans over three years. The purpose
of this study is to prepare for future clinical trials focused on a rare disease called
CLN3 disease. CLN3 disease is a neurodegenerative disease affecting children and young
adults. As part of this study, we are examining the ways in which CLN3 disease affects
the brain. To understand this impact, we will use MRI scans to compare the brains
of healthy people to brains of people with CLN3 disease. Following the initial study
visit, visits will take place at 6, 12, 18, 24, and 36 months.
Compensation will be provided following each completed study visit.
View Study Details
Connection for Latinos Caring for a Family Member with Dementia
Lead Researcher: Caroline Silva
The Healthy Aging Research Program (HARP) Connection for Latinos Caring for a Family
Member with Dementia project is seeking Hispanic/Latino participants who are at least
50 years old and providing care and support to a family member with dementia. The
purpose of the HARP Connection for Latinos project is to learn how to help Hispanic/Latino
adults who are caring for a family member with dementia improve their social relationships
and supports. The project involves two research interviews conducted remotely via
phone and/or Zoom in English or Spanish. Compensation provided. / El proyecto Conexión
para Latinos que Cuidan a un Familiar con Demencia del Healthy Aging Research Program
(HARP) está buscando participantes hispanos/latinos que tengan al menos 50 años y
que cuidan a un familiar con demencia. El propósito del proyecto HARP Conexión para
Latinos es aprender cómo ayudar a los adultos hispanos/latinos que cuidan a un familiar
con demencia a mejorar sus relaciones sociales y apoyos. El proyecto consiste en dos
entrevistas realizadas de forma remota por teléfono y / o Zoom en inglés o español.
Compensación proporcionada.
View Study Details
COVID-19 and Breastfeeding Mothers
Lead Researcher: Bridget Young
COVID-19 positive mothers:
We are seeking breastfeeding moms in the Rochester area - with a baby under 6 months
old - who have recently been diagnosed with COVID-19, ideally within the previous
7 days. The purpose of this study is to determine if there may be COVID-19 virus in
various samples we collect from mother and child. These samples include mother’s breast
milk, skin swab, saliva, and blood sample, as well as infant stool samples. These
will be taken within certain windows of time at your convenience inside the home.
Participation in this study will be for 90 days. You will be reimbursed a total of
$60 ($30 after day 10 collection and another $30 after the day 90 collection) via
check.
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Lactating mothers getting the COVID-19 vaccine:
We are seeking breastfeeding Moms in the Rochester area with infants of any age, who
will be getting the COVID-19 vaccine. We will be collecting a finger prick and small
breast milk sample from you at the following times: before you get the vaccine, 3-weeks
after your first dose, 3-weeks after your second dose, and 3 months after your final
dose (if you are still breastfeeding). You collect all samples inside your home.
Participation in this study will be for about 90 days. You will be reimbursed a total
of $50 via check.
View Study Details
COVID-19 Vaccine Studies
Lead Researcher: Ann Falsey
URMC is studying several variations of a COVID-19 vaccine. Compensation: $500-$900.
Participation Requirements: Age 18+; Have not been infected with COVID-19. To volunteer,
take our survey to find out if you qualify: https://redcap.urmc.rochester.edu/redcap/surveys/?s=XHH9MC8RMK
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
Decidetexto: Mobile Cessation Support for Latino Smokers
Lead Researcher: Anapaula Cupertino
Latino smokers (N = 618) will be randomized to one of two conditions: 1) Decídetexto
or 2) standard of care. Decídetexto is a mobile smoking cessation intervention (available
in English and Spanish) that incorporates three integrated components: 1) a tablet-based
software that collects smoking-related information to develop an individualized quit
plan, 2) a 24-week text messaging counseling program with interactive capabilities,
and 3) pharmacotherapy support. Decídetexto follows the Social Cognitive Theory as
theoretical framework. Standard of care consists of printed smoking cessation materials
along with referral to telephone quitline. Participants in both groups are given access
to free pharmacotherapy (nicotine patches or gum) by calling study phone number. All
participants will complete follow-up assessments at Week 12 and Month 6.
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
Diet And Nutrition In Cancer (The DANICA study)
Lead Researcher: Amber Kleckner
This study will assess the feasibility of delivering an 8-week Mediterranean Diet
intervention as well as the intervention's preliminary efficacy on cancer-related
fatigue among patients undergoing chemotherapy, compared to usual care. In the first
4 weeks of the intervention, we will provide the participants with food and educate
them on the principles and components of the Mediterranean Diet, while in the second
4 weeks participants will prepare their own food. In addition, we will evaluate changes
in metabolism and mitochondrial function during 4 weeks of chemotherapy and determine
how adherence to a Mediterranean diet modulates these changes during these 4 weeks.
The hypothesis is that the intervention will promote adherence to the Mediterranean
Diet. The second hypothesis is that adherence will be associated with alleviation
of fatigue and improvements in metabolic and mitochondrial function.
View Study Details
DRO 70001/ Cognitive changes in patients receiving partial brain radiation/ Michael
Milano
Lead Researcher: Sara Hardy
Cranial radiation therapy (RT), commonly used to treat benign and malignant brain
tumors, can lead to cognitive impairments in domains not related to neuroanatomic
structures directly impacted by the tumor. The study will prospectively enroll 58
patients with benign and low-grade brain tumors who will undergo partial brain RT,
with either conventionally fractionated or hypofractionated schedules. Subjects will
receive MRI scans at baseline and 6 months. Given the role of the limbic system in
key cognitive functions affected by RT, researchers have a particular interest in
characterizing MRI changes in the limbic system and thalamus in relation to memory
and related processes.
Specific Aims:
To examine objective neurocognitive changes over time. The investigators hypothesize
that they will see RT-induced neurocognitive impairment in up to 50% of patients after
cranial RT.
To examine changes in brain tissue (via MRI) induced by off-target RT in patients
with benign and low-grade brain tumors. The investigators specifically hypothesize
that comapping of RT dose and MRI changes in the thalamus and limbic system (i.e.,
thalamic nuclei, hippocampus, fornix, hypothalamus/mammillary bodies, limbic lobe,
cingulum) will be most distorted by off-target RT.
To examine the relationship between MRI changes for key neuroanatomic structures identified
in Aim 1 with objective neurocognitive testing. The investigators hypothesize that
cognitive decline will be correlated with damage revealed by MRI to limbic and thalamic
structures.
This research will help to define which neuroanatomic structures are most at risk
from RT-induced damage and will help ultimately establish new dose constraint guidelines
for important structures to improve cognitive outcomes.
View Study Details
DRO-1801: UGIC18078 Short Course Radiation Therapy: Alan Katz
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.
View Study Details
Duke 100510: Phase II study of Dose-Reduced Consolidation Radiation Therapy in Patients
with Diffuse
Lead Researcher: Louis Constine
This phase II study will evaluate whether a reduction in radiation dose and field
size will maintain a high rate of local control while minimizing the risk of acute
and late toxicity .
Hypothesis: The radiation dose and treatment volume can be safely reduced from 30
Gy to 20 Gy while maintaining high rates of local control in patients who had a negative
PET-CT scan following rituximab - containing chemotherapy.
View Study Details
Effects of Nutrition and Exercise on Chemotherapy Induced Neuropathy
Lead Researcher: Ian Kleckner
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe
side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately
there are very limited treatments for CIPN. This is a phase II randomized controlled
trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN,
to systematically investigate the potential roles of inflammation and interoception,
and to obtain data with a more accurate effect size to inform a future study.
View Study Details
ENLITE PD: Light Therapy for Impaired Sleep in Parkinson's Disease Patients
Lead Researcher: Jennifer Marsella
The study goal is to determine the best dose of light therapy needed to improve sleep
in people with Parkinson's Disease. Four groups of participants will receive bright-white
or dim-red light therapy at different times throughout the day. Eligibility: Diagnosis
of Parkinson's Disease; Significant sleep problems; Willing to wear an Actiwatch and
complete daily sleep logs; Age 45 or above
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
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
Evaluation of 3APS in Patients With Mild to Moderate Alzheimer’s Disease
The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS
compared
to placebo (inactive substance pill) in patients with mild to moderate Alzheimer’s
disease.
View Study Details
Evaluation of multiple biomarkers to estimate risk of cancer in gynecology patients
presenting with a pelvic mass
Lead Researcher: Richard Moore
The purpose of this study is to validate and refine a technology that can help physicians
determine whether
an abnormal pelvic mass in women is benign (non-cancerous) or malignant (cancerous)
using a blood test.
The specific technology is called ParsortixTM PC1 system, a semi-automated system
capable of capturing and
harvesting rare cells for subsequent analysis from blood based on the size and deformability
of the cells.
View Study Details
Exercise Intervention for LGBT Cancer Survivors
Lead Researcher: Charles Kamen
The purpose of this study is to test preliminary efficacy, as well as acceptability
and feasibility, of a dyadic exercise intervention, the current study will randomize
LGBT cancer survivors and their non-professional caregivers as dyads to either an
individual or a dyadic Exercise for Cancer Patients (EXCAP) intervention. The primary
outcome assessed will be psychological distress. Analyses will involve pre-post comparisons
of outcomes across the study arms, testing the hypothesis that a 6 week, daily, dyadic
exercise intervention will result in greater improvements in psychological distress
than an individual intervention.
View Study Details
Expanded Access Program of Ponatinib
This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic
myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic
leukemia (Ph+ALL) who have failed all available treatment options.
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
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
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. 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. Volunteer activities can be
done from your home, such as friendly calling. 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
IBMT19183 / Lipe / JNJ-68284528MMY3002 / MMY / CARTITUDE-4
Lead Researcher: Brea Lipe
The purpose of this study is to compare the efficacy of JNJ-68284528 with standard
therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide
and Dexamethasone (DPd).
View Study Details
IBRS19007 / FLEX Registry / Ajay Dhakal
Lead Researcher: Ajay Dhakal
The FLEX Registry will be implemented to operate as a large-scale, population based,
prospective registry. All patients with stage I to III breast cancer who receive MammaPrint®
and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX
Registry, which is intended to enable additional study arms at low incremental effort
and cost. FLEX Registry will utilize an adaptive design, where additional targeted
substudies and arms can be added after the initial study is opened.
View Study Details
IBRS19182 / CAPItello-291 / Ajay Dhakal
Lead Researcher: Ajay Dhakal
Phase III, double-blind, randomised study assessing the efficacy of capivasertib +
fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced
(inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression
on or after AI therapy.
View Study Details
IBRS20001, Falkson, PrE0113, Breast cancer, Pelareorep Avelumab Paclitaxel
Lead Researcher: Carla Falkson
The purpose of this study is to find out the possible anti-cancer effect of pelareorep
in combination with chemotherapy [paclitaxel] and avelumab in treating a type of breast
cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor
2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized
(cancer that has spread in your body). The study will investigate if pelareorep in
combination with paclitaxel and avelumab is more effective than paclitaxel alone,
or pelareorep and paclitaxel. The safety of the combination treatments will also be
evaluated.
View Study Details
IGIE18138 / MK-3475- 859-00 KEYNOTE-859 / Richard Dunne
Lead Researcher: Richard Dunne
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).
View Study Details
IGIH19161, Hezel, NuTide:121, Hepatoboliary, NUC-1031
Lead Researcher: Aram Hezel
NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin,
in patients with previously untreated advanced biliary tract cancer.
The primary hypotheses are:
The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the
gemcitabine plus cisplatin standard of care
The combination of NUC-1031 plus cisplatin increases overall response rate compared
to the gemcitabine plus cisplatin standard of care
View Study Details
IGIP19162, Hezel, D-US-60010-001, Pancreas, Irinotecan Liposomal Injection
Lead Researcher: Aram Hezel
The purpose of this study is to look at the efficacy and safety of Irinotecan liposome
injection in combination with other approved drugs used for cancer therapy, namely
5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine
treatment in improving the overall survival of patients not previously treated for
metastatic pancreatic cancer.
View Study Details
IGUB19002 / NIAGARA / Chunkit Fung
Lead Researcher: Chunkit Fung
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with
Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant
Treatment in Patients with Muscle-Invasive Bladder Cancer
View Study Details
IGUB20054, Fung, SGN22E-002, Urothelial Cancer, enfortumab vedotin (EV), pembrolizumab
Lead Researcher: Chunkit Fung
This study will test an experimental drug (enfortumab vedotin) alone and with different
combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor
(CPI) that is used to treat patients with cancer of the urinary system (urothelial
cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter
or urethra. Some parts of the study will look at locally-advanced and metastatic urothelial
cancer, which means the cancer has spread to nearby tissues or to other areas of the
body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC),
which is cancer at an earlier stage that has spread into the muscle wall of the bladder.
This study will look at the side effects of enfortumab vedotin alone and with other
anticancer therapies. A side effect is a response to a drug that is not part of the
treatment effect. This study will also test if the cancer shrinks with the different
treatment combinations.
View Study Details
IGUK19181, Sahasrabudhe, MK6482-005, Renal Cell Carcinoma, Everolimus
Lead Researcher: Deepak Sahasrabudhe
The primary objective of this study is to compare belzutifan to everolimus with respect
to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors
Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
and to compare everolimus with respect to overall survival (OS). The hypothesis is
that belzutifan is superior to everolimus with respect to PFS and OS.
View Study Details
IGYO18058 / Tesaro-FIRST / Richard Moore
Lead Researcher: Richard Moore
Ovarian cancer is a heterogeneous disease, characterized by complex molecular and
genetic changes. The high expression of vascular endothelial growth factor (VEGF)
receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic
acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance
of disease response. Given the unmet medical need of participants with advanced or
metastatic ovarian cancer, this study design will enable investigators to provide
participants with current SOC for ovarian cancer for the duration of the study. This
is a global, multicenter, randomized, double-blind, controlled Phase 3 study that
will primarily compare progressive survival rate of PD-L1 positive patients and also
to compare progression-free survival (PFS) of all participants with Stage III or IV
high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination
therapy, dostarlimab, and niraparib to SOC platinum-based combination therapy. The
currently recommended SOC therapy for the first line treatment of Stage III or IV
ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent
and maintenance bevacizumab. Participants will receive SOC during the chemotherapy
Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent
bevacizumab use must be determined prior to randomization at cycle 2. Approximately
1228 participants will be enrolled into the study and the duration of the study will
be approximately 78 months.
View Study Details
IHEM17093 / PAC203 / Jane Liesveld
Lead Researcher: Jane Liesveld
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating
200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients
with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 348
patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately
232 patients) or to P/C therapy (approximately 116 patients)
Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/
Post-essential Thrombocythemia Myelofibrosis
Intervention/treatment: Drug-Pacritinib
View Study Details
ILEU17106 / ARO-021 / Jane Liesveld
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
ILEU18011 / Kristen O'Dwyer
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
ILEU18074 / GMI-1271-301 / Jane Liesveld
Lead Researcher: Jane Liesveld
This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin
antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared
to chemotherapy alone. The safety of uproleselan when given with chemotherapy will
also be investigated in patients with relapsed/refractory AML
View Study Details
ILEU18153 / PTC299 in R / R Acute Leukemias / Michael Becker
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
ILEU19039 / PrECOG / Kristen O'Dwyer
Lead Researcher: Kristen O'Dwyer
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages
of 18 and 65 will be randomized to receive gilteritinib or midostaurin during induction
and consolidation. Patients will also receive standard chemotherapy of daunorubicin
and cytarabine during induction and high-dose cytarabine during consolidation.
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
ILUN19174, Mulford, QUILT-2.023, NSCLC, N803
Lead Researcher: Deborah Mulford
This is a phase 3, open-label, 3-cohort, randomized study to compare the safety and
efficacy of N-803 in combination with the current standard of care (experimental arms)
versus standard of care alone (control arms), as first-line treatment for subjects
with stage 3 or 4 advanced or metastatic NSCLC. 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 that 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 after the first dose of
study drug.
View Study Details
ILYM17047 / KTE-C19-105 (ZUMA-5) / Carla Casulo
Lead Researcher: Carla Casulo
This study will enroll approximately 160 adult subjects who have relapsed or refractory
(r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see
if their disease responds to this experimental product and if this product is safe.
Axicabtagene ciloleucel is made from the subjects own white blood cells which are
genetically modified and grown to fight cancer. An objective response rate of 70%
is targeted.
View Study Details
ILYM17064 / RSRB70432 / Paul Barr
Lead Researcher: Paul Barr
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and
Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL
View Study Details
ILYM18152 / VLS-101-0001 / Paul Barr
Lead Researcher: Paul Barr
This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics,
immunogenicity, and efficacy of VLS-101, an antibody-drug conjugate (ADC) that targets
receptor tyrosine kinase-like orphan receptor 1 (ROR1) on cancer cells. The study
is evaluating VLS-101 in patients with previously treated hematological cancers.
View Study Details
ILYM19167, Reagan, mRNA-2752-P101, Lymphoma, mRNA-2752
Lead Researcher: Patrick Reagan
The clinical study will assess the safety and tolerability of escalating intratumoral
doses of mRNA 2752 in patients with relapsed/refractory solid tumor malignancies or
lymphoma.
View Study Details
IMLT19000, Turner, RPL-16-001, Solid Tumor, RP1, Nivolumab
Lead Researcher: Rachael Turner
RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study
of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or
refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended
Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
View Study Details
Immune Modulators for Treating COVID-19
Lead Researcher: Christopher Palma
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents
for the
treatment of moderately or severely ill patients infected with severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each
agent with
respect to speed of recovery, mortality, illness severity, and hospital resource utilization.
Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use
at the
local clinics, including remdesivir (provided). The SoC may change during the course
of the
study based on other research findings. Comparisons of the agents among themselves
is not a
research objective.
The study population corresponds to moderately and severely ill patients infected
with the
coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already
hospitalized for treatment of COVID-19 infection as well as patients being treated
for
COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital.
Patients both in and out of the ICU are included in the study population.
View Study Details
IMMY16088 / STOMP / Brea Lipe
Lead Researcher: Brea Lipe
This study will independently assess the efficacy and safety of 10 combination therapies
in 11 arms, in dose-escalation/-evaluation and expansion phases, for the treatment
of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple
myeloma (NDMM). The combinations to be evaluated are:
Arm 1: Selinexor + dexamethasone + pomalidomide (SPd)
Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete
Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete
Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd)
Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete
Arm 6: Selinexor + dexamethasone + carfilzomib (SKd)
Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM
Arm 8: Selinexor + dexamethasone + ixazomib (SNd)
Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd)
Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd)
Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd)
Selinexor pharmacokinetics:
PK Run-in (Days 1-14):
Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation
Phase (i.e., Arm 4 [SPVd], Arm 6 [SKd], Arm 8 [SNd], Arm 9 [SPEd], Arm 10 [SBd], and
Arm 11 [SDPd]) will also first be enrolled to a pharmacokinetics (PK) Run-in period
until 9 patients have been enrolled to this period to evaluate the PK of selinexor
before and after co-administration with a strong CYP3A4 inhibitor.
View Study Details
IMMY17015 / Cellectar / Brea Lipe
Lead Researcher: Brea Lipe
Part A of this study evaluates CLR 131 in patients with select B-cell malignancies
(multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic
lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM),
marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell
lymphoma (DLBCL) who have been previously treated with standard therapy for their
underlying malignancy. Part B (CLOVER-WaM) is a pivotal efficacy study evaluating
IV administration of CLR 131 in patients with WM that failed Bruton's tyrosine kinase
inhibitors (BTKi).
View Study Details
IMMY18128 / Seattle / Brea Lipe
Lead Researcher: Brea Lipe
This trial will study SEA-BCMA 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. In the first part, participants get SEA-BCMA by itself.
This part of the study will find out how much SEA-BCMA should be given for treatment
and how often. It will also find out how safe the treatment is and how well it works.
In the second part of the study, participants will be given both SEA-BCMA and dexamethasone.
Dexamethasone is a drug that can be used to treat multiple myeloma. The part will
study whether SEA-BCMA and dexamethasone are safe when used together.
View Study Details
IMMY19114 /CC-220-MM-001/ Brea Lipe
Lead Researcher: Brea Lipe
This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study
consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, 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; and the expansion of
the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple
Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
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.
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
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
Lorcaserin for Treating Patients with Dravet Syndrome (Epilepsy)
Lead Researcher: Inna Hughes
There is a Core Study and an Extension Phase. The Core Study will include a Pre-randomization
(Baseline) and a Randomization (Treatment) Phase. The Pre-randomization Phase will
include a Screening/Baseline Period (4 weeks), during which the subjects will be assessed
for eligibility. Once the Screening and Baseline procedures have been completed and
eligibility has been established, the subjects will be randomized to 1 of 2 treatment
groups in a ratio of 1:1 and will receive lorcaserin or placebo for 14 weeks. All
subjects who complete the Core Study will be eligible to enter the 16-week Open-label
Extension Phase. Eligibility: Aged 2 or older with a diagnosis of Dravet syndrome.
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
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.
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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.
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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.
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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.
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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.
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Mindfulness to Reduce Loneliness in Older Caregivers
Lead Researcher: Autumn Gallegos greenwich
The objective of this pilot study is to provide initial evidence of the role of mindfulness
training in improving social disconnectedness - including social isolation and feelings
of loneliness - in older caregivers for family members with Alzheimer's Disease and
Related Dementias. Participants will be randomly assigned to one of two study arms
where they will use either a (1) smartphone-based MBSR app (Headspace) or (2) active
control (breathing app) for 14 days. Loneliness and quality of social interactions
will be assessed using end-of-day diaries at initial visit and 14-days after enrollment.
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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.
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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.
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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.
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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.
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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.
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NRG GU005 SBRT vs IGRT and Hypo-fractionated IRT Intermediate Risk Prostate
Lead Researcher: Yuhchyau Chen
This randomized phase III trial studies how well stereotactic body radiation therapy
works compared to intensity-modulated radiation therapy in treating patients with
stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor
cells and shrink tumors. 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. Stereotactic body radiation therapy may
work better in treating patients with prostate cancer.
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NRG GU007 / CGUP19100 Androgen Deprivation Therapy in high risk 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.
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NRG HN001/ Individualized Treatment for Naso-pharyngeal Carcinoma EBV positive/
Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
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.
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NRG LU005/ Chemo-radiation versus Chemo-radiation plus Atezolizumab/ Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation)
with or without atezolizumab works in treating patients with limited stage small cell
lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells,
by stopping them from dividing, or by stopping them from spreading. Radiation therapy
uses high energy x-rays to kill tumor cells and shrink tumors. 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 chemoradiation with or without atezolizumab may work better in treating patients
with limited stage small cell lung cancer.
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NRG-BN003/ Observation versus Irradiation for Meningioma/ Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
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.
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NRG-LU002/ Maintenance Systemic Therapy/ Yuhchyau Chen
Lead Researcher: Michael Milano
This randomized phase II/III trial studies how well giving maintenance chemotherapy
with or without local consolidation therapy works in treating patients with stage
IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel,
pemetrexed disodium, erlotinib hydrochloride, 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. Local consolidation therapy such as
radiation/stereotactic body radiation or surgery may kill cancer cells left after
initial treatment. Giving maintenance chemotherapy and local consolidation therapy
together may work better than maintenance chemotherapy alone in treating patients
with stage IV non-small cell lung cancer.
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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.
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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.
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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.
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Parent and Children Conversations about COVID-19
Lead Researcher: Karl Rosengren
This is a study that will examine conversations parents are having with their children
with respect to the situation caused by COVID-19. Furthermore, we will examine how
stress related to the pandemic influences family dynamics. Rochester area parents
with at least one child ages 3-7 may be eligible to complete this survey. Participants
will fill out a 35-minute online survey. Participants that complete the survey will
be eligible to win a $25 gift card.
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PBRN00002 / ANBL00B1 / Peds Neuroblastoma Biomarker / Angela Girvin
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.
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PBRT14096 / ANBL1232 / Risk Factors in Neuroblastoma / Angela Girvin
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.
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PBRT17119 / ACNS1422 / Angela Girvin
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.
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PCCB17098 / APEC1621 / APEC1621SC / MATCH / Angela Girvin
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.
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PCCO15102 / APEC14B1 / EveryChild Protocol / Angela Girvin
Lead Researcher: Angela Girvin
This study gathers health information for 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.
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PCCS13065 / ALTE11C2 / Angela Girvin
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.
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Pediatric Acute Kidney Injury in COVID-19
Lead Researcher: Susan Martin
This study is an observational registry of children with or suspected to have SARS
CoV2
(COVID-19) admitted to pediatric intensive care units (PICU). This registry will help
describe the prevalence, rate and severity of acute kidney injury (AKI) in children
with
Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry
will be developed using a point prevalence methodology and then full retrospective
review.
Once a week, from April through June 2020, data collection will occur in "real-time"
to
estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The
operational definition of "patients under investigation" (PUIs) will be used to identify
the
denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test
positive, test negative, test pending, or test unavailable. The primary aim of this
study is
to deliver a global, objective data driven analysis of the burden of AKI in virus
positive
patients or patients under investigation (PUI) who are admitted to the pediatric intensive
care unit.
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PGUK19093 / ANBL1821 / Angela Girvin
Lead Researcher: Angela Girvin
This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab
work with or without eflornithine in treating patients with neuroblastoma that has
come back (relapsed) or that isn't responding to treatment (refractory). Drugs used
in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them
from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies,
such as dinutuximab, may induce changes in the body's immune system and may interfere
with the ability of tumor cells to grow and spread. Eflornithine blocks the production
of chemicals called polyamines that are important in the growth of cancer cells. Giving
eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work
better in treating patients with relapsed or refractory neuroblastoma.
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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.
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PHEM15022 / PIDTC-6901 / Jeffrey Andolina
Lead Researcher: Jeffrey Andolina
This study is a prospective evaluation of children with Severe Combined Immune Deficiency
(SCID) who are treated under a variety of protocols used by participating institutions.
In order to determine the patient, recipient and transplant-related variables that
are most important in determining outcome, study investigators will uniformly collect
pre-, post- and peri-transplant (or other treatment) information on all children enrolled
into this study.
Children will be divided into three strata:
Stratum A: Typical SCID with virtual absence of autologous T cells and poor T cell
function
Stratum B: Atypical SCID (leaky SCID, Omenn syndrome and reticular dysgenesis with
limited T cell diversity or number and reduced function), and
Stratum C: ADA deficient SCID and XSCID patients receiving alternative therapy including
PEG-ADA ERT or gene therapy.
Each Group/Cohort Stratum will be analyzed separately.
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PHEM15023 / PIDTC-6903 / Jeffrey Andolina
Lead Researcher: Jeffrey Andolina
Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which
bone marrow transplantation (BMT) has been shown to be curative. However the risks
of transplantation are high and not all patients with CGD may need to undergo this
high risk procedure. This study will determine the long term medical condition and
daily functioning of participants with CGD after a transplant and if possible, compare
these results to participants who do not undergo a transplant.
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PHEM16142 / B0661037/ CV185-325/ Apixaban, Venous Thromboelism / Craig Mullen
Lead Researcher: Craig Mullen
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring
anticoagulation for the treatment of a VTE.
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Physical and Mental Health in Cancer Survivors
Lead Researcher: Yeates Conwell
The purpose of this study is to understand mental health, physical health, and social
support in
cancer survivors who have recently completed cancer treatment. This may be a challenging
time for
cancer survivors and understanding this period will help us to improve survivorship
care.
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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.
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PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
The objective of this study is to evaluate the safety of long-term treatment with
Kuvan.
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Plant-Based Nutrition in Metastatic Breast Cancer
Lead Researcher: Thomas Campbell
This research will examine the feasibility of conducting a strict whole-food, plant-based
dietary intervention in women with stable metastatic breast cancer currently undergoing
conventional treatments. In addition, this research will provide preliminary data
on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting
cancer prognosis and overall health using advanced imaging, various blood biomarkers
linked to cancer progression, and numerous symptom questionnaires.
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PLEU15048 / ACCL1333 / CV185-155 / Angela Girvin
Lead Researcher: Angela Girvin
The purpose of this study is to compare the effect of a blood thinning drug called
Apixaban versus no administration of a blood thinning drug, in preventing blood clots
in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including
asparaginase, and have a central line (a catheter inserted for administration of medications
and blood sampling)
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PLEU16073 / AALL1521/ Angela Girvin
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.
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PLEU16099 / AAML1531 / Angela Girvin
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
PLEU18029 / AALL1631 / Angela Girvin
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
PLEU19018 / PBMTC ONC1701/ Jeffrey Andolina
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 absence of NGS-MRD (next
generation sequencing minimal residual disease) before receiving a hematopoietic cell
transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be
screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are
pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen
as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive
will be treated as per treating center standard and will be followed in an observational
cohort (HCT center standard of care).
View Study Details
PLEU19145/ AAML18P1 / Angela Girvin
Lead Researcher: Angela Girvin
This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free
remission in patients with chronic myeloid leukemia in chronic phase. When the level
of disease is very low, it's called molecular remission. TKIs are a type of medication
that help keep this level low. However, after being in molecular remission for a specific
amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is
not yet known whether stopping tyrosine kinase inhibitors will help patients with
chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.
View Study Details
PLEU19175 / AALL1732 / Angela Grivin
Lead Researcher: Angela Girvin
This phase III trial studies whether inotuzumab ozogamicin added to post-induction
chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL)
improves outcomes. This trial also studies the outcomes of patients with mixed phenotype
acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL
therapy without inotuzumab ozogamicin. 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. This trial will also study the outcomes of patients
with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma
(B-LLy) when treated with high-risk ALL chemotherapy.
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. Other aims of this study include investigating whether
treating both males and females with the same duration of chemotherapy maintains outcomes
for males who have previously been treated for an additional year compared to girls,
as well as to evaluate the best ways to help patients adhere to oral chemotherapy
regimens. Finally, this study will be the first to track the outcomes of subjects
with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia
(MPAL) when treated with B-ALL chemotherapy.
View Study Details
PLEU20095 / AAML1831 / Angela Girvin
Lead Researcher: Angela Girvin
This phase III trial compares standard chemotherapy to therapy with CPX-351 and/or
gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without
FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and
gemtuzumab ozogamicin, 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. CPX-351 is made up of daunorubicin and cytarabine and is made in a way
that makes the drugs stay in the bone marrow longer and could be less likely to cause
heart problems than traditional anthracycline drugs, a common class of chemotherapy
drug. Some acute myeloid leukemia patients have an abnormality in the structure of
a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for
development, functioning, growth and reproduction) inside each cell that tell the
cell what to do and when to grow and divide. FLT3 plays an important role in the normal
making of blood cells. This gene can have permanent changes that cause it to function
abnormally by making cancer cells grow. Gilteritinib may block the abnormal function
of the FLT3 gene that makes cancer cells grow. The overall goals of this study are,
1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine
on people with newly diagnosed AML to find out which is better, 2) to study the effects,
good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts
of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during
and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy
may work better in treating patients with acute myeloid leukemia compared to standard
chemotherapy alone.
View Study Details
PMLT12010/ ALTE05N1 / Angela Girvin
Lead Researcher: Angela Girvin
This clinical trial keeps track of and collects follow-up information from patients
who are currently enrolled on or have participated in a Children's Oncology Group
study. Developing a way to keep track of patients who have participated in Children's
Oncology Group studies may allow doctors learn more about the long-term effects of
cancer treatment and help them reduce problems related to treatment and improve patient
quality of life.
View Study Details
PMLT18041 / AGCT1531 / Angela Girvin
Lead Researcher: Angela Girvin
This 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
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
PrEP Communication Study
Lead Researcher: Chen Zhang
We will conduct an interview among Primary Care Providers, which may take up to 30
minutes. We will ask questions regarding your attitudes or opinion regarding PrEP
care, and your experience on patient-provider communication during practice. Eligibility:
(1) 18 years or older, (2) primarily practice in NY state, (3) practice as a primary
care provider and have prescription privileges.
View Study Details
PROMISE - For Pregnant Women
Lead Researcher: Sheree Toth
The PROMISE Program is for low income adult pregnant women and their babies once they
are born. If you participate, you would have a 75% chance of receiving free counseling
through the Child Parent Program for 6-12 months, which can strengthen your relationship
with your baby and promote positive parenting. You would also receive a referral to
a local community agency that can help with your pregnancy, and securing needs.
Counseling and study visits can be completed online or in person. You would be asked
to complete 4-7 study visits, starting during pregnancy and ending when your baby
turns 15 months old. You can receive up to $325 by completing study visits.
View Study Details
PSAR16117 / ARST1431 / Angela Girvin
Lead Researcher: Angela Girvin
This randomized phase III trial studies how well combination chemotherapy (vincristine
sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan
hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus
in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues,
such as muscle), and has an intermediate chance of coming back after treatment (intermediate
risk). Drugs used 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.
Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth. It is not yet known whether chemotherapy
plus temsirolimus is more effective than chemotherapy alone in treating patients with
intermediate-risk rhabdomyosarcoma.
View Study Details
Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure
Lead Researcher: Mehmet Aktas
The purpose of this study is to determine if patients who receive an early radiofrequency
ablation for Atrial Fibrillation will have fewer hospitalizations, unplanned office
visits, and emergency room visits than those patients treated with medical therapy
alone.
View Study Details
RBRT19176, Milano, A071801, Metastatic Brain Disease, Radiation
Lead Researcher: Michael Milano
This phase III trial studies how well single fraction stereotactic radiosurgery works
compared with fractionated stereotactic radiosurgery in treating patients with cancer
that has spread to the brain from other parts of the body and has been removed by
surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy
that delivers a single, high dose of radiation directly to the tumor and may cause
less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple,
smaller doses of radiation therapy over time. This study may help doctors find out
if fractionated stereotactic radiosurgery is better or worse than the usual approach
with single fraction stereotactic radiosurgery.
View Study Details
REALIZE: CVL-865 to Treat Epilepsy
Lead Researcher: Trenton Tollefson
This placebo-controlled, double-blind trial is designed to assess the efficacy, safety
and tolerability profile of CVL-865 as adjunctive treatment in subjects with drug-resistant
focal onset seizures. Subjects will be randomized into one of three arms in a 1:1:1
ratio: one of two formulations of the study drug and placebo.
For more information, go to Realizestudy.com
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
Return of Individual Research Results
Lead Researcher: Erika Augustine
This study involves one 60-90 minute recorded interview during which we will ask about
your views of the return of individual research data to subjects. You will be compensated
$40 for participating. To participate, you must be a parent of a child with a rare
neurological disease, an IRB representative, a Sponsor, a Clinician or a Clinical
Researcher.
View Study Details
RGIC19164, Qiu, EA2182, Colon/Rectal, Capecitabine, Fluorouracil, Mitomycin,
Lead Researcher: Haoming Qiu
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation)
therapy works in comparison to standard-dose chemoradiation in treating patients with
early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil,
and capecitabine, work in different ways to stop the growth of tumor cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving
chemotherapy with radiation therapy may kill more tumor cells. This study may help
doctors find out if lower-dose chemoradiation is as effective and has fewer side effects
than standard-dose chemoradiation, which is the usual approach for treatment of this
cancer type.
View Study Details
RGUP20037, Zhang, NRG-GU008, Prostate Cancer, Abiraterone Acetate,Apalutamide, Prednisone
Lead Researcher: Hong Zhang
This phase III trial studies how well adding apalutamide, abiraterone acetate, and
prednisone to the usual hormone therapy and radiation therapy works compared to the
usual hormone therapy and radiation therapy in treating patients with node-positive
prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor
cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of
prostate cancer cells. Drugs, such as apalutamide, may help stop or slow the growth
of prostate cancer cell growth by blocking the androgens. Abiraterone acetate blocks
some of the enzymes needed for androgen production and may cause the death of prostate
cancer cells that need androgens to grow. Prednisone may help abiraterone acetate
work better by making tumor cells more sensitive to the drug. Adding apalutamide and
abiraterone acetate with prednisone to the usual usual hormone therapy and radiation
therapy after surgery may stabilize prostate cancer and prevent it from spreading
or extend time without disease spreading compared to the usual approach.
View Study Details
RLUN20039, Chen, S1827, Extensive Stage Lung Small Cell Carcinoma, Prophylactic Cranial
Irradiation
Lead Researcher: Yuhchyau Chen
This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic
cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone
in treating patients with small cell lung cancer. MRI scans are used to monitor the
possible spread of the cancer with an MRI machine over time. PCI is radiation therapy
that is delivered to the brain in hopes of preventing spread of cancer into the brain.
The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients'
lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread
of the cancer) may be at least as good as the combination of PCI with MRI scans.
View Study Details
RLUN20118 / NRG-LU007 / Qiu
Lead Researcher: Haoming Qiu
This phase II/III trial compares the effect of adding radiation therapy to the usual
maintenance therapy with atezolizumab versus atezolizumab alone in patients who have
already received atezolizumab plus chemotherapy for the treatment of small cell lung
cancer that has spread outside of the lung or to other parts of the body (extensive
stage). 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. Radiation therapy uses high energy x-rays to kill tumor
cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may
extend the time without extensive small cell lung cancer growing or spreading compared
to atezolizumab alone.
View Study Details
RTOG 1008 Phase II/III Chemo-Radiation in High Risk Salivary Gland tumors/ Yuhchyau
Chen
Lead Researcher: Hong Zhang
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used
in chemotherapy, such as 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 whether radiation therapy is more effective when given together with chemotherapy
or alone after surgery in treating salivary gland tumors.
PURPOSE: This randomized phase II/III trial is studying radiation therapy with or
without chemotherapy to see how well it works in treating patients with high-risk
malignant salivary gland tumors that have been removed by surgery.
View Study Details
RTOG 1071 / N0577 (Codel): Study of Radio-therapy with Concomitant and Adjuvant Temozolomide
Lead Researcher: Yuhchyau Chen
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as temozolomide, 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 whether
giving radiation with concomitant and adjuvant temozolomide versus radiation with
adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.
View Study Details
RTOG 1216/ RHAN13055/ Surgery and Postoperative Radiation/ Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
This phase II/III trial studies how well radiation therapy works when given together
with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating
patients with high-risk stage III-IV head and neck cancer the begins in the thin,
flat cells (squamous cell). 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. Drugs used in chemotherapy, such as cisplatin and docetaxel, work
in different ways to stop the growth of tumor cells, either by killing the cells or
by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere
with the ability of tumor cells to grow and spread. 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. The purpose
of this study is to compare the usual treatment (radiation therapy with cisplatin
chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy,
and using the usual treatment plus an immunotherapy drug, atezolizumab.
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
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
SGIM19105, Linehan, 4142-17, pancreatic and colorectal cancer, VX15/2503, ipilimumab,
and nivolumab
Lead Researcher: David Linehan
This randomized phase I trial studies how well anti-semaphorin 4D (anti-SEMA4D) monoclonal
antibody VX15/2503 with or without ipilimumab or nivolumab work in treating patients
with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal
cancer that has spread to the liver and can be removed by surgery. Monoclonal antibodies,
such as anti-SEMA4D monoclonal antibody VX15/2503, ipilimumab, and nivolumab, may
interfere with the ability of tumor cells to grow and spread.
View Study Details
SGM Competency in Oncology
Lead Researcher: Charles Kamen
This study is a single-arm, open-label trial of a sexual and gender minority (SGM)
competence training program at Wilmot Cancer Institute (Wilmot) and its regional care
locations (e.g., Wilmot Medical Oncology, Wilmot Radiation Oncology, Gynecological
Oncology, Highland Hospital, Pluta Cancer Center). Results will be descriptive in
nature and will be used to inform a R01 grant application.
The investigators will train Wilmot personnel (physicians, nurses, other providers,
staff, and administrators) at each care location using a validated, two-hour long
SGM curriculum created by the Fenway Institute and tailored for oncology. The investigators
will collect data from all personnel on knowledge and attitudes about SGM patients
before and after the training. After the training is complete, the investigators will
recruit 5 SGM patients and 5 heterosexual/cisgender (H/C) patients from each care
location to provide data on their satisfaction with care, outcomes, and experiences.
View Study Details
Silverlon to reduce radiation dermatitis/ Julie Wolf
Lead Researcher: Julie Wolf
The purpose of this study is to see if a silver-nylon dressing (Silverlon®, Argentum
Medical) is useful for the prevention or treatment of radiation dermatitis in patients
receiving radiation therapy to the breast.
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 T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
The purpose of the study is to determine whether T900607-sodium is effective and safe
in
treating hepatocellular carcinoma, a type of liver cancer.
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
STUDY00005613: RLUN20119 / A081801 / Chen
Lead Researcher: Yuhchyau Chen
This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy
versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell
lung cancer that has been removed by surgery. 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 cisplatin, pemetrexed, carboplatin, 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. The purpose of
this trial is to find out if the addition of pembrolizumab to usual chemotherapy is
better or worse than usual chemotherapy alone for non-small cell lung cancer.
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
SWOG 1806 Chemo-Radiotherapy with / without Atezolizumab in localized muscle Invasive
Bladder cancer
Lead Researcher: Michael Cummings
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.
Chemotherapy drugs, 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
The Early Treatment for Retinopathy of Prematurity Study (ETROP)
The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to
test the
hypothesis that earlier treatment in carefully selected cases will result in an overall
better visual outcome than treatment at the conventional CRYO-ROP threshold point
in the
disease.
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
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With
an Experimental Injection Catheter
The purpose of this study is to determine the optimum effective dose of recombinant
plasmid
DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct
injection
catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.
View Study Details
Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating
Patients With Hematologic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs
used in
chemotherapy use different ways to stop cancer cells from dividing so they stop growing
or
die. Combining chemotherapy with donor peripheral stem cell transplantation may allow
the
doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation
with
fludarabine and donor peripheral stem cell transplantation in treating patients who
have
hematologic cancer.
View Study Details
UBMT15029 / Liesveld Cord Blood IIT / Omar Aljitawi
Lead Researcher: Omar Aljitawi
This study is a single-center, treatment protocol with 4 possible preparative regimens,
designed to validate the process of umbilical cord blood stem cell transplantation
at our institution.
View Study Details
UBMT16009 / MSKCC15 / Michael Becker
Lead Researcher: Michael Becker
The purpose of this study is to study the impact of stem cell dose on outcome after
autologous transplant.
View Study Details
UBMT17044 / HBO-UBC / Omar Aljitawi
Lead Researcher: Omar Aljitawi
The UCB transplant is a type of stem cell transplant used to treat cancer of the blood
or lymph glands. The UCB transplant has advantages over other types of transplants
such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced
risks of contagious infections, and the availability for immediate use. The UCB transplant
is also associated with a lower incidence of graft versus host disease, or GvHD (in
GvHD, the transplanted graft attacks the recipient organs).
View Study Details
UBMT17083 / STUDY00001522 / Omar Aljitawi
Lead Researcher: Omar Aljitawi
Patients with Multiple Myeloma who are considered for high-dose therapy and autologous
transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute
(WCI) will be be approached to participate in this trial. Eligible patients who choose
to participate will be randomized so that half receive one hyperbaric oxygen therapy
session prior to hematopoetic stem cell infusion and half will not. All subjects will
have their blood counts monitored closely and time to count recovery will be compared
between the two groups.
View Study Details
UBRS19042 / UVA / Ajay Dhakal
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
UCCS19090 / health exercise intervention/ Kah PohLoh
Lead Researcher: Kah poh Loh
This is a pilot study to evaluate the feasibility of a mobile health exercise intervention
(GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid neoplasms receiving
hypomethylating agents.
View Study Details
UCCS19151, Janelsins, Cancer, Cognitive Assessment via Electronic Platform
Lead Researcher: Michelle Janelsins-Benton
The purpose of this study is to test the feasibility (acceptability and usability)
and usefulness of the CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative
Research) system, a patient-facing portal able to collect and produce reports for
clinicians on Patient Reported Outcome Measurement Information System (PROMIS-Cognitive
Function/Anxiety/Depression) outcomes via MyChart and NIH Toolbox, an inperson brief
objective cognitive function battery. This study will aim to determine the value of
the CAMPFIRE system for patients and providers as a tool for monitoring cognitive
symptoms throughout the course of chemotherapy
View Study Details
UGIC18095 / 00003244 / Richard Dunne
Lead Researcher: Richard Dunne
The purpose of this study is to evaluate the treatment of patients with locally advanced
rectal cancer for complete response to neoadjuvant chemotherapy without the use of
radiation and surgery.
View Study Details
UGIE17037 / Dunne mFOLFOX + Chemo IIT / Richard Dunne
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
UGIP20027, Dunne, CA209-7WU, Pancreatic Ductal Adenocarcinoma, SX-682, Nivolumab
Lead Researcher: Richard Dunne
The main purpose of this research study is to determine the maximum tolerable dose
(MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic
ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy
treatment without evidence of disease progression.
View Study Details
UGUB20041, Fung, HCRN GU18-343, Urinary Bladder Neoplasms, Cabozantinib, Atezolizumab
Lead Researcher: Deepak Sahasrabudhe
This is an open-label phase II study assessing the activity of cabozantinib combined
with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma
who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy.
Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every
3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients
will receive three cycles of treatment prior to cystectomy unless they discontinue
treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw
consent.
View Study Details
UGUK17036 / Fung RCC Carevive Pilot IIT / Chunkit Fung
Lead Researcher: Chunkit Fung
To determine if Carevive software, which monitors treatment-related toxicities and
then generates self-care management plans for these symptoms, will be feasible to
implement among patients with metastatic renal cell carcinoma (RCC). Additionally
for collection of preliminary data on treatment-related toxicities, quality of life,
distress level, and drug adherence.
View Study Details
UGUP17050 / Deepak Cisplatin Pilot IIT / Deepak Sahasrabudhe
Lead Researcher: Deepak Sahasrabudhe
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness
to enzalutimide in patients with CRPC by affecting AR function.
View Study Details
UGUP18071 / DORA / Chunkit Fung
Lead Researcher: Chunkit Fung
The purpose of this study is to compare any good and bad effects of using radium-223
along with docetaxel chemotherapy treatment versus using docetaxel alone.
View Study Details
UGYO17017 / MD Andersen / Richard Moore
Lead Researcher: Richard Moore
The goal of this clinical research study is to evaluate a method involving a blood
test, called CA-125, that may be helpful in the early detection of ovarian cancer
in women who are at low risk.
View Study Details
ULAB03012 / LEO / Richard Burack
Lead Researcher: Walter Burack
The goal of this infrastructure grant is to establish and maintain a cohort of over
12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research
that identifies clinical (including co-morbid diseases), epidemiologic (including
lifestyle and other exposures), host genetic, tumor, and treatment factors, as well
as the interaction among these factors, on short and long-term outcomes. These efforts
will identify new approaches to improve the survival and well-being of NHL patients.
View Study Details
ULEU07047 / RSRB20123 / Michael Becker
Lead Researcher: Michael Becker
This study is being performed to develop assays to determine the impact of the therapy
patients receive for treatment of AML or MDS and to determine if these tests can identify
those patients who are at a greater risk for having their disease relapse.
View Study Details
ULEU18122 / Huselton WashU AML IST / Eric Huselton
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
ULUN18075/ RSRB72835 / Deepinder Singh/ Lung 3 vs 5 Fx SBRT
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
ULYM17025 / ILyAD / Jonathan Friedberg
Lead Researcher: Jonathan Friedberg
Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable
outcomes in patients with numerous cancers, there has never been a thorough study
of vitamin D treatment in subjects undergoing treatment for cancer. The purpose of
this study is to evaluate whether modification of vitamin D levels in the blood, through
supplementation, can improve outcomes.
View Study Details
ULYM18040 / DLBCL / Carla Casulo
Lead Researcher: Carla Casulo
The overarching goals of this study are to measure levels of circulating tumor DNA
(ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess
the change in ctDNA during treatment in order to prospectively identify markers of
treatment failure, and to use ctDNA as a future tool for response adapted therapy.
View Study Details
ULYM18086 / acalabrutinib -Barr IIT / Paul Barr
Lead Researcher: Paul Barr
The main purpose of this research study is to find out if the combination of acalabrutinib
and high frequency low dose subcutaneous rituximab is safe and effective in patients
who have previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL).
View Study Details
UMDS18092 / Mendler MDS Pilot IIT / Jason Mendler
Lead Researcher: Jason Mendler
The primary objective of this study is to determine the safety and tolerability of
combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes
(MDS). A secondary objective is to determine the response to treatment (based on bone
marrow and peripheral blood findings). A tertiary objective is to determine the impact
of therapy on health-related quality of life (HRQOL) and patient-reported outcomes
(PRO). A quaternary (scientific) objective is to determine the impact of treatment
on both hematopoietic and stromal cell populations within the bone marrow of MDS patients.
View Study Details
UMLT18037 / Mayo MC17C1 / Richard Dunne
Lead Researcher: Richard Dunne
This early phase I trial studies the side effects of ketoconazole and how well it
works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole
may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced
rash.
View Study Details
UMLT19130 / Weight Loss / Richard Dunne
Lead Researcher: Richard Dunne
The main purpose of this research study is to determine if the use of a nutritional
supplement and exercise improve or worsen cachexia.
View Study Details
UMMY18067 / RPCI Lipe Lenalidomide IIT / Brea Lipe
Lead Researcher: Brea Lipe
This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete
Freund's adjuvant together with sargramostim in treating patients with newly diagnosed
multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made
from survivin peptide may help the body build an effective immune response to kill
cancer cells that express survivin. Incomplete Freund's adjuvant may help stimulate
the body's immune response to a vaccine treatment. Colony-stimulating factors, such
as sargramostim, may increase the production of blood cells. Lenalidomide may stop
the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Giving SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant and sargramostim
before or after the start of lenalidomide maintenance therapy may be a better treatment
for multiple myeloma.
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UMMY18121 / Amgen Deno Smol Lipe IIT / Brea Lipe
Lead Researcher: Brea Lipe
This study will assess the safety and tolerability of denosumab in smoldering multiple
myeloma subjects as well to see if denosumab can reduce subjects' risk of getting
multiple myeloma.
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Upper GI Tract Cancer: 12 week home-based exercise study
Lead Researcher: Richard Dunne
We would also like to find out if this exercise intervention improves physical performance,
day-to-day function, quality of life, and how the exercise may affect markers of inflammation
in the blood over time.
Cancer cachexia is a complex condition that can result in weight loss, muscle weakness,
and/or tiredness, and may affect your normal daily activities and quality of life.
Cachexia is common in patients with upper gastrointestinal tract cancers (esophageal,
stomach, bile duct or liver cancer, and pancreatic cancer). There is little information
on how these symptoms may develop or change as cachexia progresses, or how exercise
may help improve these symptoms. Currently more information is needed on how physical
performance and quality of life is affected by cachexia. There are no drugs approved
for cachexia so understanding cachexia and its effect on the body may guide the development
of interventions to help other patients with cancer cachexia.
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URCC 3705/ Genotoxicty Assessment / Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
The purpose of the research study is to evaluate an automated, laser-based technique
for measuring DNA damage caused by radiation during cancer treatment in immature red
blood cells.
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USAR17101 / BMS Deepak IIT / Deepak Sahasrabudhe
Lead Researcher: Deepak Sahasrabudhe
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
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Vaping/ Peter A. Wyman
Lead Researcher: Peter Wyman
Rates of adolescent vaping are increasing rapidly. Current high school student use
of electronic vaping products (EVPs) rose from 1.5% in 2011 to 20.8% in 2018 - an
increase from 220,000 to 3.05 million adolescent users. Effective, school-based interventions
are urgently needed to protect adolescents from initiating or continuing use of electronic
vaping products (EVPs). This study leverages a state-supported prevention initiative
to test the effectiveness of a promising intervention that trains 8th-9th grade student
peer leaders to deliver school-wide vaping prevention campaigns with ongoing adult
mentoring. If study hypotheses are supported, the study will provide the first evidence
of a school-based preventive intervention that reduces adolescent vaping behaviors,
as well as insight into how peer communications can be harnessed to prevent vaping.
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Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric
MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well vemurafenib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations
that have spread to other places in the body and have come back or do not respond
to
treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the
enzymes
needed for cell growth.
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