A Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus Physician's Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-based Therapy and/or Complete Tumor Resection in Stage IV Melanoma
Primary Objective:
- To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer
survival than subjects randomized to physician's choice including interleukin-2 and/or
dacarbazine/temozolomide and/or complete tumor resection.
Secondary Objective:
- To determine frequency of adverse events in subjects randomized to HSPPC-96.
Eligibility Assessment:
(The following assessments must be obtained within three weeks prior to randomization into
the study)
- Medical history and physical examination (including EGOG score, evidence of
immunosuppression);
- CT/MRI of the chest, abdomen and pelvis;
- Clinical examination;
- CT/MRI of the brain;
- Complete Blood Count with differential including platelets;
- Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4);
- Renal function tests (BUN and creatinine);
- Liver function tests (bilirubin, AST, ALT);
- Serum pregnancy test for all women of childbearing potential.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
C-100-21
NCT00039000
March 2002
December 2005
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Birmingham, Alabama 35294 | |
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 | |
Louisville, Kentucky 40207 | |
Kansas City, Kansas 66160 | |
Hackensack, New Jersey 07601 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Eugene, Oregon | |
Milwaukee, Wisconsin | |
Lebanon, New Hampshire | |
Tulsa, Oklahoma |