A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) with Pazopanib (P) or Gemcitabine (G) with Docetaxel (T) in Previously Treated Subjects with Advanced Soft Tissue Sarcoma. Save

Date Added
March 13th, 2012
PRO Number
Pro00015882
Researcher
Daniel Reuben
Keywords
Cancer, Cancer/Sarcoma
Summary

The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma. Screening tests will be done to ensure subjects are eligible to participate in this study. If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will be ?randomized? into one of the two study groups: Group 1 or Group 2. Subjects in Group 1 will receive Gemcitabine 1000 mg/m2 intravenously (directly into a vein) on Day 1 and Day 8 and Pazopanib 800mg by mouth daily. Subjects in Group 2 will receive Gemcitabine 900 mg/m2 intravenouslyon Day 1 and Day 8 and Docetaxel 100 mg/m2 intravenously on Day 8. Both groups will be in 21 day cycles. Both groups will be asked to complete 2 ?quality of life? questionnaires, on their first visit, then at 6 weeks (2nd cycle), 18 weeks (6th cycle) and at the end of study treatment. Subjects will be followed for up to 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174) Save

Date Added
March 12th, 2012
PRO Number
Pro00016094
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

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

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer Save

Date Added
January 10th, 2012
PRO Number
Pro00015069
Researcher
Megan Ruppel
Keywords
Cancer, Cancer/Breast
Summary

The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor.

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

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications Save

Date Added
August 16th, 2011
PRO Number
Pro00011805
Researcher
Robert Stuart
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
?Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
?Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, and at Six Month Follow-Up Save

Date Added
June 23rd, 2011
PRO Number
Pro00010437
Researcher
James Bearden
Keywords
Cancer, Cancer/Breast, Cancer/Lymphoma, Memory Loss, Mental Health, Non-interventional
Summary

This study is being conducted to better understand how common cognitive difficulties are by using cognitive testing measures, as well as self-report measures. It is believed that cognitive difficulties associated with cancer and chemotherapy treatments may be related to increased inflammation and other processes that can impact inflammation in the body; inflammation and inflammation-related processes are associated with cognitive difficulties in other diseases, and the same may be true for cancer and cognition. Inflammation is the basic way in which the body reacts to infection, irritation or other injury. This study will evaluate these relationships in this study by assess subject's blood and DNA.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
800-486-5941
research@srhs.com

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

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