An Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients with Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment with Single-Agent Nivolumab Save

Date Added
May 23rd, 2017
PRO Number
Pro00064564
Researcher
Theodore Gourdin
Keywords
Cancer/Genitourinary
Summary

The overall goal of this study is to see if adding radiation to a combination of chemotherapy agents can help to reduce the size of tumors in patients with metastatic clear-cell renal cell carcinoma (ccRCC) who have previously received nivolumab and progressed. The kind of radiation used is called hypo-fractionated stereotactic radiation (STR). The chemotherapy agents that will be administered will be a combination of ipilimumab and nivolumab.

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

A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma. Save

Date Added
January 10th, 2017
PRO Number
Pro00061532
Researcher
Theodore Gourdin
Keywords
Cancer/Genitourinary
Summary

This study will be conducted at MUSC and the VA on adult patients with newly diagnosed metastatic prostate cancer. The purpose of this study is to see if giving several cycles of docetaxel before androgen deprivation therapy (degarelix) improves outcomes, including survival rates, among men with metastatic prostate cancer. Patients will undergo screening assessments to see if they are eligible. Once on study, subjects will receive 6 cycles of docetaxel (cycle = 21 days). During cycle 4, subjects will begin taking degarelix every 28 days for up to 7 months.

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

Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy Save

Date Added
November 15th, 2016
PRO Number
Pro00059559
Researcher
Michael Lilly
Keywords
Cancer/Genitourinary
Summary

The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer. The term ?AGE? (advanced glycation endpoints) refers to sugar-derived metabolites that are linked to lifestyle choices and can contribute to cancer.

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

A Randomized, Double-Blinded, Phase II Study of Maintenance Pembrolizumab versus Placebo after First-line Chemotherapy in Patients with Metastatic Urothelial Cancer Save

Date Added
August 9th, 2016
PRO Number
Pro00057764
Researcher
Theodore Gourdin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.

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

A Multi-center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma Save

Date Added
August 9th, 2016
PRO Number
Pro00055991
Researcher
Michael Lilly
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

The purpose of this study is to evaluate the progression free survival (PFS) , based on investigator radiologic review, of AGS-16C3F compared to axitinib in adult subjects with metastatic renal cell carcinoma. The time frame for PFS is 24 months.

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

A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse after Radical Prostatectomy Save

Date Added
May 24th, 2016
PRO Number
Pro00054476
Researcher
Michael Lilly
Keywords
Cancer/Genitourinary, Prostate, Vaccine
Summary

This study is for adult male patients who have recently undergone radical prostatectomy and are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational drug. Subjects will have screening tests to determine eligibility. If the subject is eligible and wishes to enroll, he will begin study drug and will have drug administered at designated intervals over about 20 weeks . After the 20 week period, the subject will enter a follow up period for about a year and a half. The total amount of time on study is anticipated to be about 2 years.

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

A Phase Ib/II Clinical Study of BBI608 in Combination with Standard Chemotherapies in Adult Patients with Advanced Gastrointestinal Cancer Save

Date Added
July 28th, 2015
PRO Number
Pro00046142
Researcher
Carolyn Britten
Keywords
Cancer/Gastrointestinal, Cancer/Genitourinary
Summary

The purpose of this research study is to determine the safety of BBI608 and the highest dose of this drug that can be given to people safely in combination with six different anti-cancer regimens. BBI608 is a newly discovered drug that may treat cancer by killing cancer stem cells; a highly malignant portion of cancer cells that are fundamentally responsible for malignant growth, relapse and metastatic spread of the disease. This drug has been used in other research studies, and information from those research studies suggests that BBI608 may help treat cancer by killing the highly malignant cancer stem cells. In the laboratory studies, BBI608 given in combination with these standard anti-cancer drugs has been shown to effectively kill cancer cells.
The study is sponsored by Boston Biomedical. The investigator in charge of this study is Carolyn Britten, MD. It is expected that about 21-24 participants will take part in this research study in each of the above combinations globally and 5 will take part at MUSC.

Institution
MUSC
Recruitment Contact
David Longshore
843-792-8113
longshor@musc.edu

A Phase II Randomized, Double-Blind Study of Dalantercept plus Axitinib Compared to Placebo plus Axitinib in Patients with Advanced Renal Cell Carcinoma Save

Date Added
May 13th, 2014
PRO Number
Pro00033034
Researcher
Theodore Gourdin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study is for individuals with renal cell carcinoma (RCC). The purpose of this study is:

?To find out whether the study treatment can stop your RCC from growing, or prevent it from growing as fast as it would without dalantercept.
?To evaluate the safety of the study treatment in subjects with RCC.
?To find out if the study treatment has an effect on biomarkers (molecules that indicate how well you respond to study treatment) in your blood and/or tissue.

Participants will receive a dose of dalantercept or placebo (a substance with inactive drug that looks the same as dalantercept) plus axitinib. It is expected that a participant will be on this study for a variation of time (total duration will vary per subject).

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@musc.edu

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer. Save

Date Added
April 28th, 2014
PRO Number
Pro00034803
Researcher
Michael Lilly
Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients that have prostate cancer that has spread and are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days. The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@musc.edu

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial Save

Date Added
September 17th, 2013
PRO Number
Pro00028856
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better.

There are 2 treatment groups in this study:
1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles
2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-4111
khawthorne@selfregional.org

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