A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients with Prostate Cancer Progression on Enzalutamide or Abiraterone

Date Added
January 21st, 2020
PRO Number
Pro00095537
Researcher
Michael Lilly

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This is a phase II study that will look at the safety and effectiveness of the investigational drug opaganib in participants with metastatic prostate cancer. The study drug, opaganib has been studied in a clinical trial to find a safe dose level. The results of this clinical trial and other lab studies have indicated that opaganib may be effective at slowing tumor growth. Patients will be eligible to participate in this study if they have prostate cancer that has progressed (gotten worse) on their current therapy of either abiraterone or enzalutamide. Participants will received either 250mg or 500mg of opaganib by mouth twice a day. Patients will continue on study drug until the development of progressive disease, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.

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

Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

Date Added
December 2nd, 2019
PRO Number
Pro00094604
Researcher
Theodore Gourdin

List of Studies

Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The purpose is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab,

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

Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)

Date Added
November 18th, 2019
PRO Number
Pro00094342
Researcher
Chanita Hughes-Halbert

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for African American men with prostate cancer. The purpose of this study is to see how prostate cancer treatment affects men's ability to work.

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

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Date Added
September 26th, 2019
PRO Number
Pro00092663
Researcher
Theodore Gourdin

List of Studies

Keywords
Cancer/Genitourinary
Summary

This study is for patients with an advanced rare genitourinary cancer. The purpose is to test the good and bad effects of the drugs called cabozantinib, nivolumab and ipilimumab, when given in combination.

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

A PHASE II STUDY OF DOSE-DENSE GEMCITABINE PLUS CISPLATIN (DDGC) IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER WITH BLADDER PRESERVATION FOR THOSE PATIENTS WHOSE TUMORS HARBOR DELETERIOUS DNA DAMAGE RESPONSE (DDR) GENE ALTERATIONS

Date Added
September 18th, 2019
PRO Number
Pro00093086
Researcher
Theodore Gourdin

List of Studies

Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with invasive bladder cancer. The purpose of this study is to determine if a certain group of patients can avoid standard surgery called a radical cystectomy with pelvic lymph node dissection based on whether their tumor has a certain genetic marker and the stage of their cancer after finishing chemotherapy.

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

A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with Nivolumab in Subjects with Advanced Solid Tumors

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

The purpose of this study is to determine at what dose the study drug (ASP1948) is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients.The screening period for this study can take up to 28 days. The treatment period consists of up to 48 weeks of initial treatment, followed by up to 45 weeks of follow up. If you quality and are willing to continue in the re-treatment period (receiving the study drug again), you will be in the study for an additional 48 weeks.

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

PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER

Date Added
March 19th, 2019
PRO Number
Pro00086529
Researcher
David Marshall

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

This study is for men who have prostate cancer. The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy of the prostate to standard systemic therapy (SST), which is used to treat prostate cancer.

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

Clonal Emergence and Regression During Radium-223 Therapy for Metastatic Prostate Cancer

Date Added
December 21st, 2018
PRO Number
Pro00081670
Researcher
Michael Lilly

List of Studies

Keywords
Cancer/Genitourinary
Summary

This study is for patients with metastatic prostate cancer receiving radium-223 as their standard of care therapy. The researchers will collect blood and urine samples from patients before, during and after the radium-223 therapy. The researchers will compare these samples to observe how the treatment has affected different cancer markers.

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

Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients

Date Added
November 20th, 2018
PRO Number
Pro00082574
Researcher
Michael Lilly

List of Studies

Keywords
Cancer/Genitourinary
Summary

The overall goal of this study is to identify a safe dose of the metabolic supplement, Chitosan that can help reduce AGE (advanced glycation endproducts) levels in patients with prostate cancer. Chitosan is a naturally occurring substance found in shellfish. This study will be using Chitosan prepared from the shells of cold-water shrimp. Chitosan is approved by the FDA for use in wound dressings and has been used in published clinical trials for weight loss but is not approved for the purposes of this study. AGEs are a type of metabolite, or substance, found in food and produced in the body. The researchers helping conduct this study have found a potential link between AGE levels and cancer. Participation in this study will require three study visits over the course of about 3 months. During these visits subjects will be asked to provide blood and stool samples as well as complete surveys about their quality of life.

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

PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCER

Date Added
February 28th, 2018
PRO Number
Pro00075522
Researcher
David Marshall

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients with prostate cancer that has a risk of getting worse. The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy.

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



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