Double blind randomized prospective trial of levamisole/placebo in stage I cutaneous malignant melanoma.

One hundred and fifty-six Stage I, Clark's Level III, IV, and V cutaneous malignant melanoma patients were randomized, 83 to Levamisole and 73 to placebo. One hundred and thirty-seven patients were evaluable. Their median follow-up time was 5 years. The 2 groups were comparable in terms of patient characteristics, except for a slightly higher percentage of Clark's level III in the placebo group (57.8 vs 52%). Severe toxicity leading to discontinuation of the medication occurred in 32 patients in the Levamisole arm, versus 10 in the placebo arm. Thirty per cent of patients receiving Levamisole have recurred in comparison with 26% of those on placebo treatment, and despite a trend in the delay of appearance of distant metastasis in the patients receiving Levamisole (30 months versus 9 months in the placebo patients), this drug does not appear to be effective in altering the disease-free survival or the survival of Stage I patients in the dosage schedule utilized in this study.