A randomised phase II study of carmustine alone or in combination with tumour necrosis factor in patients with advanced melanoma.

Author(s): Jones AL, O'Brien ME, Lorentzos A, Viner C, Hanrahan A, Moore J, Millar JL, Gore ME

Affiliation(s): Department of Medicine, Royal Marsden Hospital, London, U.K.

Publication date & source: 1992, Cancer Chemother Pharmacol., 30(1):73-6.

Publication type: Clinical Trial; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Laboratory data suggest a synergistic interaction between carmustine (BCNU) and tumour necrosis factor (TNF) in melanoma. We therefore studied the activity of 200 mg/m2 BCNU given alone or in combination with 88 micrograms/m2 recombinant human TNF-alpha (rhTNF alpha) as a daily i.v. infusion for 5 days at 48-day intervals to patients with metastatic melanoma. In this randomised phase II trial, the rate of response to BCNU alone was 20% [95% confidence interval (CI), 2%-38%], and this was not improved by the addition of TNF (response rate, 10.5%; 95% CI, 1.3%-33%). Toxicity was higher in the combination arm, and there was no difference in survival.