Phase II trial of recombinant tumor necrosis factor in disseminated malignant melanoma

Twenty-one patients with disseminated malignant melanoma received recombinant tumor necrosis factor (TNF), 150 μg/m² intravenously on days 1- 5 every 2 weeks for four cycles and then every 3 weeks. Recombinant TNF produced no meaningful palliation. One patient (5%) attained an objective response of nodal, but not visceral, disease, which lasted 3 weeks. The median time to progression was 4 weeks. The median survival was 7.7 months. Ninety percent of patients developed mild to severe cytokine 'flu.' Ten percent developed significant hepatic toxicity (AST > 3 times normal). As a single agent, recombinant TNF is not likely to palliate disseminated malignant melanoma. However, combinations of recombinant TNF and cytotoxic or immune modulatory agents, particularly gamma interferon, may merit further investigation.