Phase II Study of Recombinant a-Interferon in Malignant Melanoma

Ninety-seven evaluable patients with measurable. advanced. malignant melanoma were treated with recombinant a in­ terferon in a cooperative phase II efficacy trial. whose primary objective was to estimate the response rate. Interferon (rlFN a-2a, Roferon-A) was injected subcutaneously daily for 70 days. Dose was escalated in four steps from three million units to 36 million units over ten days. Eight patients re­ sponded objectively and six patients (6%) had a complete response. The median duration of complete response was 11 months. Patients achieving complete response had only cu­ taneous, nodal, or pulmonary disease: some had extensive prior therapy; some could tolerate no more than three million units per day. Few patients could tolerate the target dose of 36 million units daily for 70 days. Limiting toxicity was pri­ marily fatigue . Interferon in tolerable doses is effective in a small subset of patients with melanoma. Comparison of pub­ lished trials of dacarbazine and recombinant a interferon indicates the two drugs have similar activity .