A phase III multi-institutional randomized study of immunization with the gp100: 209–217(210M) peptide followed by high-dose IL-2 compared with high-dose IL-2 alone in patients with metastatic melanoma

摘要: CRA9011 Background: In a phase II study, 13 (42%) of 31 patients with metastatic melanoma receiving high-dose (HD) IL-2 plus gp100:209–217(210M) peptide experienced objective responses (S.A. Rosenberg, et al, Nature Medicine 4: 321–327, 1998). Other studies showed lower response rate (RR) but no randomized have been done. Methods: A prospective III trial was conducted at 21 centers 185 patients. Eligibility: stage IV or locally advanced cutaneous melanoma, HLA A0201, brain metastases, eligible for HD IL-2, and previous gp100:209–217(210M). Arm 1 received alone (720,000 IU/kg/dose) 2 + Montanide ISA followed by IL-2. The primary clinical response. Secondary objectives were toxicity, disease free/progression free survival, immunologic quality life. Central typing, pathology review, blinded assessment done the NIH. data monitoring by...