The primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
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Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Berkeley, California, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Vista, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
...and 67 more locations