A Phase II Study of Neoadjuvant Therapy with Cisplatin, Docetaxel,Panitumumab Plus Radiation Therapy Followed by Surgery in Patients with Locally Advanced Adenocarcinoma of the Distal Esophagus Save

Date Added
October 5th, 2009
IRB Number
18942
Researcher
Chadrick Denlinger
Keywords
Cancer, Cancer/Other, Drug Studies, Esophagus
Summary

The goal of this study is to improve the chances that your tumor shrink and even disappear by adding a special drug to routine chemotherapy and radiation before surgery. This drug, named panitumumab, blocks a target at the molecular level that when "turned on" causes reactions that make your tumor grow and spread.

Patients participating in this study will receive panitumumab in combination with two other chemotherapy drugs called cisplatin and docetaxel every 2 weeks for 10 weeks. Patients will also receive radiation therapy at the same time as the chemotherapy starting on week 5. Patients will also receive other tests and procedures that are part of regular cancer care.

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

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

Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell Histology Save

Date Added
October 5th, 2009
IRB Number
18419
Researcher
Carol Sherman
Keywords
Cancer, Cancer/Lung, Drug Studies, Lung
Summary

The purpose of this trial is to test the experimental drug combination of pemetrexed and cisplatin, given with radiation. This study is testing whether this experimental combination of drugs combined with radiation will prove to be more effective in eliminating non-small cell lung cancer without increasing side effects.

Patients who participate in this study will be randomly assigned to one of two treatment groups. Patients in the first group will receive pemetrexed + cisplatin + radiation therapy. Patients in the second group will receive etoposide + cisplatin + radiation therapy. All chemotherapy is given intravenously.

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

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

AN INTERGROUP PHASE II CLINICAL TRIAL FOR ADOLESCENTS AND YOUNG ADULTS WITH UNTREATED ACUTE LYMPHOBLASTIC LEUKEMIA Save

Date Added
October 5th, 2009
IRB Number
18147
Researcher
Robert Stuart
Keywords
Cancer, Cancer/Leukemia, Drug Studies
Summary

The purpose of this study is to improve the outcome of adolescents and young adults with ALL. This study will evaluate the effectiveness and side effects of an intensive program using multiple chemotherapy drugs that have been designed for children but is now being used in young adults. Patients who participate in this study will be given a series of leukemia treatments that are divided into four sequential and different chemotherapy combinations. A final course of treatment, referred to as 'maintenance therapy' will be given for an additional 30-32 months. Male patients may receive radiation therapy.

Institution
MUSC
Recruitment Contact
Jackie Nguyen
843-792-9756
nguyenj@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

South Carolina Alzheimer's Disease Clinical Core (ADCC) Save

Date Added
October 5th, 2009
IRB Number
11246
Researcher
Jacobo Mintzer
Keywords
Aging, Alzheimers, Anxiety, Brain, Dementia, Depression, Drug Studies, Genetics, Geriatrics, Memory Loss, Mental Health
Summary

This study is sponsored by ADCC at MUSC. Phase I is open to participants and consists of a clinical diagnostic interview only. This is a one time visit and does not have study medication associated with the study. There is no compensation for this study.

Institution
MUSC
Recruitment Contact
Marie Corbin
843-740-1592
corbinm@musc.edu