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

A Randomized Controlled Trial of Immediate versus Delayed Insertion of Implanon in Postpartum Adolescents Save

Date Added
October 5th, 2009
IRB Number
19133
Researcher
Angela Dempsey
Keywords
Adolescents, Breastfeeding, Drug Studies, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

With current standard of care practice, Implanon, a long acting reversible contraceptive measure is placed at the 6 week post partum visit. This study is examining whether or not it is more beneficial to have the Implanon placed prior to leaving the hospital. If you are between 15-21 years of age and are considering using Implanon as your post partum birth control, then you may be eligible to qualify. Study participants have a 50% chance of having Implanon placed prior to leaving the hospital and must commit to completing a baseline questionnaire at enrollment and three follow-up questionnaires by phone at 3,6, and 12 months after delivery. Compensation is available. Please contact the coordinator for more details.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7008
schaffne@musc.edu

Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease Save

Date Added
October 5th, 2009
IRB Number
18471
Researcher
Richard Silver
Keywords
Autoimmune disease, Drug Studies, Scleroderma
Summary

This 24 month study will test to efficacy and safety, via comparison, of the drugs Mycophenolate and Cyclophosphamide (Cytoxan). The study requires monthly office visits for follow up and drug dispensation.
Study drug is supplied free of charge during the duration of this trial. Most office visits and testing are done as standard of care, so the subjects insurance is billed.

Institution
MUSC
Recruitment Contact
Kelley Gibson
843-792-5290
gibsonke@musc.edu

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy Save

Date Added
October 5th, 2009
IRB Number
18814
Researcher
Frank Brescia
Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is being done to find out if adding trastuzumab to breast radiation therapy will be more effective than breast radiation therapy alone in preventing the occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body.
Trastuzumab is called a targeted therapy because it targets breast cancers that make too much of a protein called HER2. Too much of the HER2 protein can cause cells to receive extra growth signals. Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2+ invasive breast cancers.
Patients will be randomized into one of two treatment groups. One group will receive radiation only, and the other group will receive Trastuzumab plus radiation therapy.

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

A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Save

Date Added
October 5th, 2009
IRB Number
19018
Researcher
David Marshall
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to find out what effects (good and/or bad) chemotherapy combined with external radiation therapy and possible removal of your bladder has on you and your cancer. The chemotherapy drugs used in this study (5-Fluorouracil, cisplatin, and gemcitabine) are not experimental drugs. This research is being done because we do not know whether one combination of drugs with radiation is superior to another in the treatment of your disease. This study uses similar therapies to the standard treatment, but chemotherapy and radiation therapy are given before removal of the bladder is considered. In this study, bladder removal is advised if, after chemotherapy and radiation, your tumor has not completely disappeared, if your tumor comes back, or if it gets larger.

Patients who participate in this trial will be randomized into two groups. Patients will receive either cisplatin and 5-FU chemotherapy and radiation twice per day OR gemcitabine chemotherapy and radiation once per day. Participation in this study may last up to 8 months with continued follow up after treatment is complete.

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

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide. Save

Date Added
October 5th, 2009
IRB Number
18252
Researcher
Anand Sharma
Keywords
Cancer, Cancer/Lung, Drug Studies, Lung
Summary

The purpose of this study is to compare the effects, good and/or bad, of three different ways to give radiation therapy. Two of the ways are experimental, while one of them is standard.

Patients who participate in this study will be randomized into one of three study groups. Those in the first group will receive radiotherapy everyday for 3 weeks plus 4 cycles of chemotherapy. Those in the second group will receive radiotherapy everyday for 7 weeks plus 4 cycles of chemotherapy. Those in the third group will receive radiotherapy everyday for 5 weeks plus 4 cycles of chemotherapy.

Institution
MUSC
Recruitment Contact
Tina Kehoe
843-792-6349
kehoet@musc.edu

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