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Therapeutic Areas: Oncology | Nephrology/Urology
Disease Category: Renal Cell Carcinoma

Trial Information

A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage? Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma.

This research study is about a personalized vaccine treatment that is made from an individual?s own tumor. This vaccine is called HSPPC-96 (Heat Shock Protein-Peptide Complex). Researchers believe that the vaccine may cause the body to attack cancer cells.
The purpose of this study is to find out if patients receiving HSPCC-96 (Oncophage?) vaccine will take longer to develop recurrence of kidney cancer or prevent its spread than patients with no vaccine treatment.
You may or may not benefit, however, it is possible that the vaccine may have a favorable effect on your survival or may slow the return of the tumor. This treatment is not available outside of the research study.
The study vaccine, HSPPC-96 will be supplied to you free of charge. All tests, procedures and radiograph follow-up that are an immediate part of the study will be covered by the study sponsor.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be eligible to participate in this research study if you:
* Are 18 years of age or older.
* Have a newly diagnosed kidney cancer that can be removed by surgery.

You are not eligible to participate in this research study if you:
* Received prior chemotherapy, hormone therapy, immunotherapy, or radiotherapy for your kidney cancer.
* Are using medications that reduce the body's immune response, called immunosuppressive drugs.
* Have current spread of cancer at other sites or previous other cancer within the last 5 years.
* Have a known distant spread of kidney cancer.
* Have an active,uncontrolled infection or other serious medical illnesses.

Lourdes Campos-Grundvig, Research Coordinator
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Phone: (212) 241-3141
Fax: (212) 876-3246
EMail: lourdes.campos-grundvig@mssm.edu

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