Clinical Protocol for the Investigation of the ProSpace™ Balloon System Save

Date Added
November 26th, 2019
PRO Number
Pro00094196
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Lymphoma, Men's Health, Prostate
Summary

The ProSpace balloon is being studied to test IF it will temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating that space will reduce the radiation dose delivered to the anterior rectum. The ProSpace balloon is composed of a bioresorbable polymer material called RESOMER. RESOMER is well studied and approved for many indications. This study will show if it will maintain that space for the entire course of prostate radiotherapy treatment and then be completely absorbed by the body over time. The balloon is considered a permanent implant because it will remain in the body for at least 30 days. The ProSpace System study will collect data to demonstrate the safety and efficacy of its indication. This device is currently investigational in the United States

Institution
MUSC
Recruitment Contact
Sarah Mulhern
843-792-9321
hcc-clinical-trials@musc.edu

Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas Save

Date Added
November 18th, 2019
PRO Number
Pro00094317
Researcher
Brian Hess

List of Studies

Silhouette
Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients that have been diagnosed with double-hit or double expressing lymphoma. The investigational drug in this study is venetoclax. The purpose of this study is T\to compare the progression-free survival (PFS) of R-chemotherapy plus venetoclax versus Rchemotherapy alone in MYC/BCL2 double-hit and double expressing lymphomas. Participants can expect to receive treatment for up to 18 weeks and followed by the study doctor for up to 10 years after being registered to the study.

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

Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA) Save

Date Added
October 22nd, 2019
PRO Number
Pro00088996
Researcher
Brian Hess

List of Studies

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

This study is for patients who have been diagnosed with relapsed (the disease has gotten worse after a period of improvement) or refractory (the disease does not respond to treatment) aggressive B-cell non-Hodgkin lymphoma .The investigational therapy in this study is tisagenlecleucel treatment. This treatment includes collecting T cells from patient's blood and changing them by gene transfer to make them recognize tumor cells. The purpose of this study is to see how well tisagenlecleucel therapy treats the disease and how safe the treatment is when compared to Standard or Care treatment. Participants can expect to be in this study for up to 60 months and in follow up for up to 15 years.

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

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011) Save

Date Added
October 10th, 2019
PRO Number
Pro00092018
Researcher
Theodore Gourdin

List of Studies

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

Adult males are being asked to volunteer because they have been diagnosed to have bladder cancer that has spread and subjects tumor has a specific type of biomarker called PD-L1 (biomarkers can help to tell us what is going on in subjects body).This is a research study to find out if experimental medications called pembrolizumab and lenvatinib, when administered together. Participants can expect to be on this study for 2 years.

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

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma Save

Date Added
September 26th, 2019
PRO Number
Pro00093207
Researcher
Brian Hess

List of Studies

Silhouette
Keywords
Cancer/Lymphoma
Summary

This study is for patients with Hodgkin Lymphoma. The purpose is to decide if adding the study drug nivolumab to standard chemotherapy will extend a patient's time without disease more than or less than if adding the study drug brentuximab vedotin to standard chemotherapy.

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

A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study) Save

Date Added
September 7th, 2019
PRO Number
Pro00090813
Researcher
Michael Lilly

List of Studies


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

This study is for patients who have been diagnosed to have metastatic Castration-resistant Prostate Cancer (mCRPC). The purpose of this study is to find out if experimental medication called olaparib in combination with approved drug called abiraterone, will work and be safe for the treatment of the disease (mCRPC). Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. Olaparib (tradename Lynparza™) is approved, by the US Food and Drug Administration (FDA) and other countries for the treatment of certain types of ovarian cancer and breast cancer. Abiraterone is already an approved medication for the treatment of some subjects with prostate cancer. This medication is indicated in combination with prednisone or prednisolone for the treatment of mCRPC. The research study is planned to go on for approximately 4 years, with visits lasting three to six hours each. Olaparib, abiraterone, and prednisone are all taken orally.

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

A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer Save

Date Added
September 1st, 2019
PRO Number
Pro00083993
Researcher
Whitney Graybill

List of Studies

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

The purpose of this study is to determine if adding the investigational drugs (TSR-042 and Niraparib) to Standard Of Care delays or prevents ovarian cancer recurrence (prevents the ovarian cancer from coming back). Once eligibility is determined, participants will begin with one of two treatment periods. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. The first treatment period is the chemotherapy treatment period, and the second one is the maintenance treatment period. It is not known how long participation in this study may last.
The Sponsor and Study Doctors cannot and do not guarantee or promise that participants will receive any benefits from this study. There is a chance by taking the study drug participants cancer may not return or the return of cancer may be delayed. It is not known whether participants would benefit from the Study Drug. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. Therefore, participants may not get any direct benefit from taking part in this study. However, what is learned in this study may help in the treatment of ovarian cancer for women around the world and may advance scientific knowledge.

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

A Phase II Study of Palbociclib (PD-0332991) in Combination with Ibrutinib in Patients with Previously Treated Mantle Cell Lymphoma Save

Date Added
August 27th, 2019
PRO Number
Pro00091524
Researcher
Irl Greenwell

List of Studies

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

This study is for subjects that have been diagnosed with mantle cell lymphoma (MCL) and have already received at least one form of treatment. This study will evaluate the effects, good and bad, of the study drugs palbociclib and ibrutinib in your type of cancer. The purpose of this study is to study the effects of an investigational combination of ibrutinib and a drug called palbociclib on MCL. The subject will be in the study for as long as you do not experience any unacceptable side effects and your cancer does not become worse.

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

A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin Save

Date Added
July 23rd, 2019
PRO Number
Pro00089429
Researcher
Robert Grubb

List of Studies

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

This study is for patient that have bladder cancer and have been treated with BCG (Bacillus Calmette-Guerin), but the cancer has returned after treatment(s). This research study is designed to test if an investigational agent named BC-819 can prevent or delay tumor recurrence in non-muscle invasive bladder cancer patients who have become unresponsive to BCG treatment.
The primary objective is to determine, for the patients with baseline CIS:The proportion that achieves a complete response after treatment with inodiftagene vixteplasmid Participants can expect to be in this study for102 weeks.

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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release Save

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies

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

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

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