Randomized trial of chlorpromazine, caffeine, and methyl-CCNU in disseminated melanoma.

One hundred and fifty-seven evaluable patients with advanced metastatic malignant melanoma were randomly assigned to receive either methyl-CCNU (MeCCNU) (200 mg/m2 orally every 6 weeks) (82 patients) or a combination of MeCCNU, chlorpromazine (50 mg/m2 im), and caffeine (600 mg/m2 sc) in the periumbilical area (75 patients). The response rate was 12% for the combination (three complete responses and six partial responses) and 11% for MeCCNU alone (two complete responses and seven partial responses). The median survival was 20 weeks and was the same for both treatments. The data support the hypothesis that caffeine and chlorpromazine do not enhance MeCCNU activity in malignant melanoma, unlike the marked enhancement seen for this drug combination in L1210 leukemia in mice.