Phase II trial of cisplatin and α-interferon in advanced malignant melanoma

Purpose: To evaluate the antitumor activity of combination cisplatin (CDDP) and α-interferon (α-IFN) in advanced, measurable metastatic melanoma. Patients and Methods: Adult patients with metastatic melanoma were required to have bidimensionally measurable lesions and a Karnofsky performance status ≥ 60%. Serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min, adequate organ and bone marrow function, and radiologic proof of the absence of brain metastases were required. CDDP 40 mg/m² intravenously (IV) on day 1 and day 8, and α-IFN 3 million units/m² subcutaneously on days 1 to 5 and 8 to 12 were administered every 3 to 4 weeks. Results: Forty-two patients were entered onto this phase II trial and were assessable for response and toxicity. Three patients achieved complete responses (CRs) that lasted 31+, 5, and 8+ months. Seven patients had partial responses (PRs) and a median response duration of 4.4 months. The overall objective response rate was 24% (95% confidence interval, 12% to 39%). Toxicities were mild. Only 11% of the courses required dose reduction of α- IFN, and three of 128 courses required CDDP dose reduction for reversible nephrotoxicity. Conclusion: The combination of moderate-dose CDDP and α-IFN as administered in this schedule is well tolerated and possesses encouraging activity in metastatic melanoma.