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
Primary Objective:
- The primary objective of this study is to determine whether subjects randomized to
receive adjuvant HSPPC-96 after surgical resection of locally advanced renal cell
carcinoma at high risk of recurrence, have improved recurrence-free survival as
compared to subjects with no adjuvant treatment.
Secondary Objective:
- Determine whether subjects randomized to receive HSPPC-96 have improved survival as
compared to subjects with no adjuvant treatment.
- Further characterize the safety profile of HSPPC-96.
Pre-Surgery
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
C-100-12 Part I
NCT00033904
June 2000
April 2007
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
McLean, Virginia 22101 | |
Kansas City, Kansas 66160 | |
Albuquerque, New Mexico 87131-5636 | |
Metairie, Louisiana 70006 | |
Anchorage, Alaska | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Eugene, Oregon | |
South Burlington, Vermont | |
Milwaukee, Wisconsin |