Effect of levamisole as a surgical adjuvant therapy for malignant melanoma.

The preliminary results of a trial in progress are reported. Two hundred patients have been enrolled in a randomized, double-blind, placebo-controlled trial of levamisole in malignant melanoma. A median followup of 20 months has been reached. Endpoints of the study include disease-free interval, interval free of visceral disease, and survival. Overall, there is a trend in favor of the levamisole group with regard to all three endpoints, but the difference is not significant. Significant differences between the control and levamisole groups are found at some, but not all, time intervals when the analysis includes only patients with stage II disease (positive lymph nodes at the initiation of the study). Although these preliminary results are encouraging, at the present time the overall curve for patients with stage II disease is not statistically significantly different when analyzed by the method of Mantel.