title: A randomised phase II study of carmustine alone or in combination with tumour necrosis factor in patients with advanced melanoma.
abstract: 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.
authors.affiliation: Department of Medicine, Royal Marsden Hospital, London, U.K.
authors.forename: A L
authors.initials: AL
authors.lastname: Jones
authors.forename: M E
authors.initials: ME
authors.lastname: O'Brien
authors.forename: A
authors.initials: A
authors.lastname: Lorentzos
authors.forename: C
authors.initials: C
authors.lastname: Viner
authors.forename: A
authors.initials: A
authors.lastname: Hanrahan
authors.forename: J
authors.initials: J
authors.lastname: Moore
authors.forename: J L
authors.initials: JL
authors.lastname: Millar
authors.forename: M E
authors.initials: ME
authors.lastname: Gore
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004357:Drug Synergism; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D014409:Tumor Necrosis Factor-alpha / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D011994:Recombinant Proteins; D014409:Tumor Necrosis Factor-alpha; D002330:Carmustine