NCT00039000

Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (planned)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	HSPPC-96 or Oncophage

Timeline

• Start date: 2002-03-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2002-06-10
• Last updated: 2012-09-07

Locations

77 sites across 9 countries: United States, Australia, Hungary, Italy, Poland, Russia, Sweden, Ukraine, United Kingdom