Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

Date Added
June 22nd, 2022
PRO Number
Pro00121172
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer
Summary

This study is for patients with invasive cancer I-IV and be scheduled to receive anti-PD-1/-L1 ICI-containing therapy. This study is being done to see if we can understand which patients will develop side effects from immune checkpoint inhibitors, and what kind of side effects they will get and can we predict long-term treatment outcomes after immune checkpoint inhibitor treatment, like which patients will have a cancer that shrinks or disappears.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

T-reg function changes: a novel immune regulatory effect underlying benefit of statin use on lethal prostate cancer

Date Added
June 21st, 2022
PRO Number
Pro00120567
Researcher
Michael Marrone

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer that can be removed by surgery. The purpose of this study is to determine whether a group of drugs called statins can help to reduce the risk of prostate cancer returning after surgery. The drug used in this study is a particular type of statin called simvastatin. Simvastatin is approved by the Food and Drug Administration (FDA) to help lower cholesterol (fatty deposits in your blood) and decrease the risk of heart disease. Its use in this research study is considered investigational, and not FDA approved for the subject's cancer. Subjects can expect to be in the active participation portion of this study for about 3 months. Afterwards, the study team may contact them or their medical providers every 6 months to follow their cancer care and collect information on their current health status.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

T-reg function changes: a novel immune regulatory effect underlying benefit of statin use on lethal prostate cancer

Date Added
June 21st, 2022
PRO Number
Pro00120567
Researcher
Michael Marrone

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer that can be removed by surgery. The purpose of this study is to determine whether a group of drugs called statins can help to reduce the risk of prostate cancer returning after surgery. The drug used in this study is a particular type of statin called simvastatin. Simvastatin is approved by the Food and Drug Administration (FDA) to help lower cholesterol (fatty deposits in your blood) and decrease the risk of heart disease. Its use in this research study is considered investigational, and not FDA approved for the subject's cancer. Subjects can expect to be in the active participation portion of this study for about 3 months. Afterwards, the study team may contact them or their medical providers every 6 months to follow their cancer care and collect information on their current health status.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100mg/m2) Every Three Weeks Versus Radiation with Low-Dose Cisplatin (40mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Date Added
June 6th, 2022
PRO Number
Pro00120883
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients who have been diagnosed with locoregionally advanced squamous cell carcinoma. The purpose of this study is to compare two usual treatment approaches to head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The usual approach for patients who are not in this study is treatment with radiation therapy combined with the chemotherapy drug cisplatin. Cisplatin is a drug approved by the Food and Drug Administration (FDA) to treat your head and neck cancer. Cisplatin can be given at different doses and at different times during radiation, but the most common way to give cisplatin is either as a high-dose every 3 weeks or a low-dose weekly during radiation. Participants can expect to be on this study for up to 7 weeks and then followed annually until disease progression.

Institution
MUSC
Recruitment Contact
Lydia Moats
864-725-7125
lydia.moats@selfregional.org

A Phase Ib Trial of Zanubrutinib in Combination with R-PolaCHP (ZaR-PolaCHP) for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

Date Added
April 26th, 2022
PRO Number
Pro00119556
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been newly diagnosed with diffuse large B cell lymphoma (DLBCL). This study is testing an "investigational" (not yet approved by the Food and Drug Administration (FDA)) combination of the drug zanubrutinib (BRUKINSA™) and a standard chemotherapy treatment called R-CHOP. This study will test the how well the drug combination works and how safe it is. The subject will be given the study drug combination in 21 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, bone marrow biopsies, and imaging scans. The subject may remain in the study for up to approximately 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Pediatric Acute Leukemia (PedAL) Screening Trial Developing New Therapies for Relapsed Leukemias

Date Added
March 11th, 2022
PRO Number
Pro00118800
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with leukemia. This study is called a screening study and we are doing this study to find better ways to diagnose and treat leukemia in children, adolescents and young adults. Bone marrow, blood, and medical information about participant's cancer and treatment will be collected. Participants can expect to be on this study for 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Date Added
February 23rd, 2022
PRO Number
Pro00118231
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with non-germinomatous germ cell tumor (NGGCT). The goal of this study is to see if radiation therapy (RT) to the spine and a portion of the brain works just as well as the standard treatment, which includes RT to the whole brain and spine, for people with NGGCT who agree to take part in this study, and whose disease responds well to induction chemotherapy, or who have no signs of disease following surgery. Participants can expect to receive treatment on this study for about 6 to 11 months, depending on which therapy they receive. After study completion, participants will continue to be followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Date Added
February 22nd, 2022
PRO Number
Pro00118193
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for newly diagnosed or previously untreated low-grade glioma (LGG). The overall goal of this study is to see if selumetinib works just as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with LGG. Selumetinib is a drug that works by blocking a protein (a basic building block of the human body) that lets cancer cells grow without stopping. Participants can expect to receive treatment on this study for about 1–2 years. After study completion, participants will continue to be followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

Date Added
February 1st, 2022
PRO Number
Pro00113673
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for participants that have been diagnosed with Medulloblastoma. The purpose of this study is to test the effectiveness of using an investigational agent called DFMO for Medulloblastoma. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to either keep participants tumor in remission or if they have active tumor, for their tumor to respond to the treatment and will also look at the safety and tolerability of DFMO. After this first day participants will be seen in clinic once every 30 days for the first 6 months of the study, after that they will be seen once every 90 days for the remainder of the study. These visits will last about 2 hours.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers

Date Added
February 1st, 2022
PRO Number
Pro00115767
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for participants with tumors from pediatric cancers and genomic/molecular testing was done as part of standard of care treatment. This is an observational study; therefore, only information about the disease and medical treatment will be collected and participants will not receive any treatments or additional medications. The sponsor, Beat Childhood Cancer, will collect and store personal health information and molecular/genomic test results, tissue samples, and bodily fluids (examples: additional tube(s) of blood, urine, bone marrow or cerebral spinal fluid) that are left over after testing or treatment is completed in a data registry and a specimen bank, and make these available for future research. Database personnel will continue to collect and store participant information from future visits, as long as they do not withdraw from participation in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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