An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS 003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) Save

Date Added
December 8th, 2014
PRO Number
Pro00021461
Researcher
Harry Drabkin
Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for subjects with newly diagnosed advanced kidney cancer who have previously consented to allow for collection of a tumor sample, which may be used to make a personalized experimental drug called AGS-003. Argos Therapeutics is sponsoring this research study using their experimental (investigational) drug AGS-003 to see if it is effective against kidney cancer. An investigational drug is a medication that is still being studied and has not been approved for use in the general population by the United States Food and Drug Administration (FDA). AGS-003 is made for subjects by using a piece of tumor collected after surgical removal of their kidneys along with a certain type of their own white blood cells. The resulting product is a type of immune cell called a dendritic cell, which is very good at activating the immune system against cancer cells.
AGS-003 can be used in combination with the approved, regular medications most often prescribed for the treatment of kidney cancer. In this study, one group of subjects will receive regular medications for kidney cancer and a second group will receive regular medications for kidney cancer plus AGS-003. An important purpose of this study is to see if treatment with AGS-003 plus regular medications is any different than treatment with regular medications alone. Subjects are expected to be enrolled in this study for approximately 3 years.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Differences in the migration and cell surface marker expression of Mesenchymal Stem Cells (MSC) obtained from the placenta and Umbilical Cord Blood Save

Date Added
November 19th, 2014
PRO Number
Pro00009198
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to determine whether there are alterations in the migration and cell surface marker expression of MSC’s obtained from the placenta and umbilical cord in uncomplicated pregnancies

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
cordells@musc.edu

Mesenchymal Stem Cells (MSC) obtained from Healthy Donor Umbilical Cords Save

Date Added
November 18th, 2014
PRO Number
Pro00037760
Researcher
Gary Gilkeson
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to obtain viable MSCs from umbilical cords in uncomplicated pregnancies. Potential donors will be screened prior to donation of umbilical cords to confirm no prevalent autoimmune disease. The overall goal is to obtain MSCs from healthy donors for eventual transfusion into patients for the treatment of autoimmune disease, specifically systemic lupus erythematosus.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-6864
baczko@musc.edu

Novel Intervention Linking Public Housing and Primary Care to Prevent Diabetes Save

Date Added
November 5th, 2014
PRO Number
Pro00036688
Researcher
Gayenell Magwood
Keywords
Diabetes, Disease Prevention, Exercise, Minorities, Obesity, Weight Control, Women's Health
Summary

The purpose of this study is to test a 24-week community based Diabetes Prevention Program. The intervention, Sisters Health And Primary CarE Uniting and Preventing Diabetes (SHAPE UP), includes: 1) 12 weekly peer group Lifestyle sessions followed by 3 monthly group sessions held in locations conveniently located near Public Housing Neighborhoods; 2) Individual health and wellness coaching during 24 week period; 3) contact with a Community Outreach Care Coordination for Referral, navigation assistance, linkage to FQHC primary care health services.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
843-792-1418
magwoodg@musc.edu

Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma Save

Date Added
October 28th, 2014
PRO Number
Pro00021940
Researcher
Saurabh Chhabra
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been been newly diagnosed with advanced (Stage III or IV) classical Hodgkin lymphoma (HL) (a cancer of the lymph nodes) and have not received any treatment for the disease. In this study, patients will receive one of two regimens (or treatment plans), either a regimen that includes an investigational drug called brentuximab vedotin (also known as ADCETRIS®) or the current standard of care treatement (this regimen/group is referred to as Arm B). The main purpose of this study is to measure how well treatment in Arm A works compared to treatment in Arm B for Hodgkin lymphoma. This study is split up into 4 different periods: Screening, Treatment, End of Treatment, and Post-Treatment Follow up. Depending upon how patients respond, their treatment period (the portion of the study where you will continue to receive study treatment) can last approximately 6 months. Patients' study participation, including post-treatment follow-up, can last up to 7 years, depending on when they start the study.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A PHASE II OPEN-LABEL, SINGLE-ARM, TWO-STAGE, MULTICENTER TRIAL OF PRACINOSTAT IN COMBINATION WITH AZACITIDINE IN ELDERLY (AGE GREATER THAN OR EQUAL TO 65 YEARS) PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) Save

Date Added
October 28th, 2014
PRO Number
Pro00029825
Researcher
Alice Mims
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients with newly diagnosed Acute Myeloid Leukemia (AML).
The purpose of this research study is to learn how well subjects with AML respond to treatment with pracinostat when it is given with azacitidine. It is also to measure how long the response will last and to evaluate the side effects. Participants can expect to be in this study until one of the following occurs: (1) you withdraw your agreement to continue to take part in this research study; (2) your AML becomes worse; (3) you have severe side effects; (4) or the research study ends.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Phase 2 Study Of Brentuximab Vedotin In Relapsed Or Refractory Non-Hodgkin Lymphoma (NHL) Save

Date Added
October 28th, 2014
PRO Number
Pro00030352
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients with relapsed or refractory non-Hodgkin lymphoma. The purpose of this research study is to find out what the side effects of Brentuximab vedotin are and whether or not it is effective in the disease or condition being studied. Participants can expect to be in this study for eight 21-day cycles and follow-up visits and/or follow-up phone calls every 12 weeks until the study is closed.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation Save

Date Added
October 28th, 2014
PRO Number
Pro00020353
Researcher
Bernadette Marriott
Keywords
Breastfeeding, Infant, Nutrition, Pregnancy, Women's Health
Summary

The primary purpose of the this study is to evaluate the quality of life of lactating mothers using an all-natural, organic, herbal tea that is currently on the market and has been commercially available for over thirty years in the United States. Compensation is available. Please call the study coordinator for more details.

Institution
MUSC
Recruitment Contact
Carolyn Finch
843-876-5795
weigleca@musc.edu

Roles of intratumor macrophages and the master chaperone for Toll-like receptors in colon cancer Save

Date Added
October 24th, 2014
PRO Number
Pro00010913
Researcher
Zihai Li
Keywords
Cancer, Cancer/Other, Men's Health, Minorities, Non-interventional, Surgery, Women's Health
Summary

This study will help to understand the roles of the immune system in controlling colon cancer. It may advance science, leading to future development of an effective treatment of colon cancer.

Institution
MUSC
Recruitment Contact
Zihai Li
843-792-1034
zihai@musc.edu

A Phase II Multi-Center Study of Bevacizumab in Combination with Ixabepilone in Subjects with Advanced Renal Cell Carcinoma. Save

Date Added
October 21st, 2014
PRO Number
Pro00027639
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients with advanced renal cell carcinoma. This is a Phase II study for the experimental treatment of kidney cancer. The drugs to be examined in this study are a combination of ixabepilone and bevacizumab. The purpose of this phase II study is to determine whether the combination of ixabepilone administered for five consecutive days and bevacizumab administered on one day, both repeated every three weeks, is effective in the treatment of kidney cancer.

Institution
MUSC
Recruitment Contact
Seth Price
843-792-6969
pricesr@musc.edu