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

Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Save

Date Added
October 21st, 2014
PRO Number
Pro00026773
Researcher
James Ravenel
Keywords
Cancer, Cancer/Lung, Lung, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with lung cancer who cannot have surgery because of the location of or advanced stage of the cancer or other serious health problems such as emphysema, diabetes, or heart disease. The purpose of this study is to find out if more intense (higher dose) radiation treatment based on the FDG-PET/CT imaging improves treatment of this cancer with the same possible damage to healthy lung tissue compared to treatment with standard radiation therapy. The higher dose radiation is aimed at the tumor. Patients will be randomized into one of two groups; Group A will receive standard radiation treatment once daily, 5 days a week for 5 weeks. They will also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Group B will receive radiation treatment once daily, 5 days a week for 3-4 weeks. This radiation treatment will be a higher dose per day than standard radiation. Patients will also receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Both groups will receive Paclitaxel and carboplatin are given by vein before radiation therapy. Both groups will also receive paclitaxel and carboplatin by vein every 21 days X 3, a total of 3 cycles of chemotherapy four to six weeks after radiation treatment is completed.

Institution
MUSC
Recruitment Contact
Scott Landreth
843-792-6429
landrets@musc.edu

Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (R05185426) Adjuvant Therapy in Patients with Surgically-Resected Cutaneous BRAF Mutant Melanoma at High Risk for Recurrence Save

Date Added
October 17th, 2014
PRO Number
Pro00021186
Researcher
Keisuke Shirai
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to find out whether vemurafenib can help prevent or delay the return of melanoma that is at a high risk of returning (Stage IIC, IIIA, IIIB or IIIC) after it has been removed surgically. The study will also assess whether the drug causes side effects in patients.
Vemurafenib was recently approved in the United States for the treatment of patients with metastatic melanoma. Vemurafenib remains an investigational drug being studied by Roche.

Institution
MUSC
Recruitment Contact
Robin Bostick
843-792-8876
bostickr@musc.edu

A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications. Save

Date Added
October 14th, 2014
PRO Number
Pro00030051
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The main purpose of this research trial is to test the investigational drug MSB0010718C at different dose levels to see if it is safe and well tolerated when given once every two weeks. Based on this information the sponsor of this study hopes to learn which dose (drug strength) could be best for treatment of subjects.
Additional purposes of the trial are to assess side effects of MSB0010718C and to find out whether MSB0010718C has anti-cancer effects. In addition, the sponsor would like to find out how MSB0010718C is processed by the body (this is called pharmacokinetic or PK research).
Approximately 380 people will participate in the expansion part of the trial. The research trial will be conducted in up to 130 medical centers in the US and Europe. About 10 of those patients will be enrolled at MUSC under the care of Carolyn Britten, MD.

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