Malignant Melanoma Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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