Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma Save

Date Added
October 5th, 2009
IRB Number
18182
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Urinary
Summary

This study is for patients with metastatic clear cell renal cell carcinoma. The purpose of this trial is to describe the gene expression of VEGF and non-VEGF angiogenic (the formation of new blood vessels) growth factor genes in kidney cancer specimens from patients with metastatic kidney cancer treated with sunitinib maleate (Sutent). Sutent® (sunitinib) is a drug that is designed to block tumor cell growth in several ways. Sunitinib targets several enzymes (proteins by your body that help cells interact with one another) on blood vessel cells and tumor cells. Several of these targets are thought to be involved in angiogenesis (making of blood vessels). Sunitinib is approved by the FDA for the treatment of advanced renal cell cancer. As a part of this study, you will have a nephrectomy (surgery to remove a kidney or part of a kidney) after your treatment with Sunitinib. Researchers are not certain what effects nephrectomies alone have on your disease. Some studies, as well as standard practice, suggest value in giving drug therapy treatment before performing nephrectomies. Therefore, in this study your surgery will be delayed until after you have been treated with Sunitinib. You will be asked to consent to provide some of your tissue from this surgery to help researchers identify tumor cells that influence growth of vascular endothelial growth factor (VEGF), a protein that is a major factor in promoting the growth of new blood vessels, and to find out more information about Sunitinib’s role in hindering this relationship. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. This clinical trial is studying how well sunitinib works when given before and after surgery in treating patients with metastatic kidney cancer that can be removed by surgery. Treatment on this trial may last up to 18 months.

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

A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy Save

Date Added
October 5th, 2009
IRB Number
18024
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate, Urinary
Summary

Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone aganist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer.

This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer. Patients will be randomly assigned to one of three study groups: radiation therapy to the prostate bed only; hormone therapy plus radiation to the prostate bed; and hormone therapy plus radiation to the prostate bed and to the pelvic lymph nodes.

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

A Multicenter, Open-Label, Single-Arm Study of YONDELIS (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment Save

Date Added
October 5th, 2009
IRB Number
15603
Researcher
John Wrangle
Keywords
Cancer, Cancer/Sarcoma, Drug Studies
Summary

The purpose of this study is to provide an experimental drug called Yondelis to eligible patients who have not responded to previous treatment. This drug has not been approved for sale by the FDA for use with your type of cancer. Safety evaluation of this drug will also occur during this study that will include physical exams, monitoring of your vital signs and side effects, and performing laboratory tests.

Patients who participate in this study will receive Yondelis as a 24-hour infusion. You may be hospitalized only for the first cycle of this treatment. You will receive treatment on day 1 of every 17 to 49 day cycle. You will visit your doctor on day 1 of each cycle and blood will be taken during the middle of each cycle and at the end of treatment.

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