A phase II trial of recombinant interferon alpha-2b and cisplatin in metastatic melanoma

In this phase II study 37 patients with metastatic melanoma were treated wi th cisplatin 100 mg/m(2) every three weeks and interferon alpha-2b 10 MU su bcutaneously three times weekly; 125 cycles were administered. Thirty-four patients were evaluable for response and all 37 patients were assessable fo r toxicity. Four patients stopped treatment with cisplatin because of sever e nephrotoxicity, and six patients stopped therapy because of other toxicit ies. Response rate was 6/34 = 18% (95% CI (confidence interval): 7%-35%). O ne patient reached complete response lasting 27 + months. Five patients obt ained partial responses with a median duration of response of 7 months (ran ge 5-15 +). Median time to progression was 2.3 months (range 1-27 +). Media n survival was 5 months (range 1-27 +). We conclude that the combination of high-dose cisplatin 100 mg/m(2) and interferon alpha-2b is associated with unacceptable toxicity. Haematological toxicity and nephrotoxicity were pro nounced and the response rate was meagre and not encouraging.