A Randomized Trial of Levamisole versus Placebo as Adjuvant Therapy in Malignant Melanoma

Abstract

We conducted a randomized double-blind trial of levamisole versus placebo as adjuvant therapy for surgical treatment of melanoma. Of 203 patients entered into the study, 104 received levamisole and 99 placebo. The distribution of prognostic variables was similar in both groups, indicating the efficacy of the randomization and the absence of bias. Three end points were analyzed: disease-free interval, time to appearance of visceral metastasis, and survival. There was no statistically significant difference between the groups regarding any of these end points. In patients with Stage I disease, there was a trend in favor of levamisole regarding time to first visceral recurrence and survival (P = 0.07). We conclude that levamisole has no benefit, as compared with placebo, as adjuvant therapy for malignant melanoma. (N Engl J Med. 1980; 303: 1143–7.)