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

Am J Clin Oncol. 1992 Jun;15(3):256-9. doi: 10.1097/00000421-199206000-00015.


Twenty-one patients with disseminated malignant melanoma received recombinant tumor necrosis factor (TNF), 150 micrograms/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 greater than 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.

Publication types

  • Clinical Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Drug Evaluation
  • Female
  • Humans
  • Male
  • Melanoma / drug therapy*
  • Melanoma / secondary*
  • Middle Aged
  • Recombinant Proteins / therapeutic use
  • Remission Induction
  • Survival Analysis
  • Tumor Necrosis Factor-alpha / therapeutic use*


  • Recombinant Proteins
  • Tumor Necrosis Factor-alpha