Multicenter, Open-label, Single-arm, Study of Enzalutamide Re-Treatment in Metastatic Castration-Resistant Prostate Cancer, As First Treatment Post-Decetaxel in Patients Who Have Previously Received Enzalutamide in the Pre-Chemotherapy Setting Save

Date Added
July 14th, 2015
PRO Number
Pro00044714
Researcher
Michael Lilly
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer and have been previously treated with enzalutamide followed by docetaxel. This experimental study is being done to study the effectiveness and safety of enzalutamide when it is administered as re-treatment, following prior enzalutamide use and treatment with docetaxel. The length of time that patients are in the study will depend on their tolerance of the study medication and the state of their disease. They will continue in the study until they show signs of disease progression or unacceptable toxicity of the study medication.

Institution
MUSC
Recruitment Contact
Mike Wheeler
843-792-2306
wheelerm@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (Orbit 3) Save

Date Added
June 23rd, 2015
PRO Number
Pro00044536
Researcher
Patrick Flume
Keywords
Drug Studies, Lung, Pulmonary
Summary

This study will see how effective Pulmaquin is in managing chronic lung infections with P. aeruginosa bacteria when given over a 48 week period to people with non-cystic fibrosis bronchiectasis.

Pulmaquin is an inhalable compound that is made up of a combination of immediate release and delayed release ciprofloxacin. Ciprofloxacin is an antibiotic used to treat infections including P aeruginosa in the lungs.This will be administered once daily by inhalation using a nebulizer, which is a device that turns liquid into a mist for inhalation.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

Randomized Trial to Prevent Vascular Events in HIV ? REPRIEVE (A5332) Save

Date Added
June 16th, 2015
PRO Number
Pro00042920
Researcher
Allison Eckard
Keywords
Cardiovascular, Cholesterol, Disease Prevention, Drug Studies, Heart, HIV / AIDS, Infectious Diseases
Summary

Pitavastatin lowers high cholesterol and triglyceride levels in the blood. The primary purpose of this study is to determine the effects of pitavastatin on lowering the traditional risk factors for cardiological events in patients who have HIV.

Institution
MUSC
Recruitment Contact
Stephanie Warth
843-792-5491
warth@musc.edu

A Phase 1B Open-Label Three-Arm Multi-Center Study to Assess the Safety and Tolerability of PF-05212384 (PI3K/mTOR Inhibitor) in Combination with Other Anti-Tumor Agents Save

Date Added
June 9th, 2015
PRO Number
Pro00027912
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is enrolling male and female patients with a diagnosis of advanced solid tumor. The purpose of this research study is to learn about the effects of and to find the best dose of the study drug, PF 05212384, when given in combination with other drugs. This study will determine the highest dose of PF-05212384 that can be tolerated when given in combination with other drugs; this PF-05212384 dose is called the maximum tolerated dose or MTD. Enrolled patients can expect to be in this study for about 6 months. They will need to visit the research site at least 12 times during the study. Patients may stay in the study until the disease gets worse or they decide to stop participating.

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

Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders Save

Date Added
June 2nd, 2015
PRO Number
Pro00042941
Researcher
Sudie Back
Keywords
Alcohol, Drug Studies, Mental Health, Military, Stress Disorders
Summary

The purpose of this study is to evaluate the effects of a medication (doxazosin) on reducing symptoms of posttraumatic stress disorder (PTSD) and alcohol use in Veterans. We will also examine the effects of doxazosin on brain activity at pre and post treatment.

Institution
MUSC
Recruitment Contact
Francis Beylotte
792-2522
beylott@musc.edu

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer Save

Date Added
October 3rd, 2013
PRO Number
Pro00017993
Researcher
Frank Brescia
Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

This study is being done for the following reasons:
?This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
?The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
?In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during your breast cancer surgery. Information about this study requirement will be explained to you in more detail later in this consent form.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer Save

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

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

Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) Save

Date Added
December 20th, 2011
IRB Number
20599
Researcher
C. Devane
Keywords
Adolescents, Autism, Drug Studies, Pediatrics, Psychiatry
Summary

MUSC, USC, and Greenville Hospital System are studying the benefits of two drugs to treat irritability in autism.

Your child may qualify if he/she:
- is 6 to 17 years old,
- has or might have autism, and
- is irritable.

If eligible, payment is available.

Low Country Contact: Stacey Wilson (843) 792-0384
Mid-State Contact: Sarah Ravan (803) 434-4536
Upstate Contact: Betsy Holbrook (864) 454-5591

Institution
MUSC
Recruitment Contact
Greg Ricalde
843-792-0384
ricalde@musc.edu

Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas Save

Date Added
March 12th, 2011
IRB Number
19663
Researcher
Scott Lindhorst
Keywords
Brain, Brain Tumor, Cancer, Cancer/Brain, Drug Studies
Summary

This study is for patients with a low grade glioma (a slow growing tumor in the brain). The purpose of this study is to compare the effects, good and/or bad, of adding the chemotherapy pill temozolomide to radiation. Temozolomide is an experimental drug for low-grade gliomas. Patients will be randomly assigned to 1 of 2 groups. One group will receive radiation alone, while the other group receives Temozolomide chemotherapy in addition to the radiation. Patients will receive radiation for 5.5 weeks; patients may also take temozolomide during the 5.5 weeks of radiation and for up to one year thereafter. Follow-up exams will occur every 3 months for 15 years.

Institution
MUSC
Recruitment Contact
Bo Keller
843-792-1286
Kellej@musc.edu

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Cemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma Save

Date Added
March 7th, 2011
IRB Number
20167
Researcher
Michael Lilly
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your transitional cell cancer to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.

Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing and are expected to be very similar in safety and effectiveness. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of your cancer and allow you to live longer.

This is a randomized trial so patients will receive one of two treatments: Arm A: Gemcitabine, cisplatin, and placebo (sugar water or salt water)OR Arm B: Gemcitabine, cisplatin, and bevacizumab (an experimental drug). Arm A is the current standard treatment for patients with this type of cancer. Your participation in this trial will continue for as long the cancer is responding to or is stabilized by the drugs and you do not have any severe side effects from the drugs.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
matsont@musc.edu

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