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

Summary 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 g/m² recombinant human TNF-alpha (rhTNF) 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.