Circulating Fibroblast Precursors in Metastatic Sarcoma Save

Date Added
June 22nd, 2011
PRO Number
Pro00010978
Researcher
Amanda Larue
Keywords
Cancer, Cancer/Sarcoma
Summary

The purpose of this project is to determine the role of fibroblasts in sarcoma metastasis. Fibroblasts are cells that are major component of the supporting and connecting structures of the body. Precursors to these tissue fibroblasts are found in our bone marrow and in our circulating blood. The study doctor will grow fibroblasts from blood samples in culture and determine the role that they play in promoting tumor cell invasion and metastasis.

Institution
MUSC
Recruitment Contact
Sara Rothmyer
843-792-1507
rothmyer@musc.edu

HOLLINGS CANCER CENTER TISSUE BIOREPOSITORY Save

Date Added
May 17th, 2011
PRO Number
Pro00009235
Researcher
Steven Rosenzweig
Keywords
Cancer, Genetics
Summary

This is not a treatment study. The Hollings Cancer Center Tissue Biorepository, (HCCTB), provides investigators with a centralized infrastructure to promote biomedical research involving the use and study of human biospecimens. The protocol outlines the fundamental aspects of how the collection, storage, and data management of specimens and related health information will be managed for the HCCTB. HCCTB will serve as the honest broker to other researchers that present with an separate valid IRB approval to utilize the specimens from the HCCTB.

Institution
MUSC
Recruitment Contact
Tricia Bentz
843-792-1753
adraleta@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 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

A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer Save

Date Added
October 5th, 2009
IRB Number
17905
Researcher
Frank Brescia
Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

The purpose of this study is to determine if adding bevacizumab to the current standard chemotherapy, namely doxorubicin, cyclophosphamide, and paclitaxel, reduces the risk of recurrence compared to standard chemotherapy alone.

Patients are stratified according to planned dose schedule of doxorubicin and cyclophosphamide. Patients are further stratified according to estrogen receptor status, lymph node involvement, and received/planned radiation and surgery treatment. Patients are randomized to 1 of 3 treatment arms in which they will receive either paclitaxel, placebo, bevacizumab, or a combination of two of these drugs.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

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

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