Autologous tumor-derived HSPPC-96 vs. physician's choice (PC) in a randomized phase III trial in stage IV melanoma

8002 Background: Vitespen (Oncophage; formerly HSPPC-96) is an autologous, tumor-derived, heat shock protein (gp96)-peptide complex vaccine that has shown signals of clinical activity in patients (pts) with metastatic melanoma, and colon and renal cancers. Methods: This phase 3 trial compares vitespen v. PC in AJCC stage IV melanoma. Pts had ECOG PS 0/1 and ≥7 g tumor tissue for vaccine production. Randomization was 2:1 favoring vitespen, and stratified by ECOG PS and AJCC substage (M1a, -b, -c). Vitespen was administered s.c. weekly for 4 weeks, then biweekly until vaccine depletion or disease progression (DP). PC treatment was any regimen including IL-2 and/or dacarbazine/temozolomide and/or tumor resection. Pts were evaluated every 3 months for 1st year, every 6 months for 2nd year, then annually until DP. Primary endpoint was overall survival (OS). OS data, based on ITT, were analyzed using 1-sided log-rank tests. Results: From Jan 2002-Sept 2004, 322 pts at 76 centers (US, Europe, Russia/Ukraine, Aus...