Combination chemotherapy plus levamisole in the treatment of disseminated malignant melanoma a southwest oncology group study

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Abstract
Patients (280) were randomized to receive either BCNU [1,3-bis(2-chloroethyl)-1-nitrosourea], hydroxyurea [BHD] and imidazolecarboxamide [DTIC], BHD plus levamisole, or high-dose DTIC plus actinomycin D. There was no difference in response rate in the 3 groups (24, 25 and 22%). Females responded better than males and, as expected, those with a better performance status responded more favorably than those with poor performance status. Patients whose primary site of melanoma was on the extremities did significantly better than those melanomas originating on the trunk or head and neck. Patients with lymphocyte counts > 2000/mm3 fared better than those with lymphopenia. Those responders who received high-dose DTIC plus actinomycin D had a significantly longer length of response than those receiving the immunotherapy limb. This was also true in those patients who had a prior disease-free interval of > 6 mo. before being placed in this study. Although there was no difference in survival from the start of treatment in all patients, those patients receiving high-dose DTIC plus actinomycin D and who had a prior disease-free interval of > 6 mo., had significantly superior survival when compared to the immunotherapy limb. The addition of levamisole to BHD does not improve response rate and may in certain subsets be detrimental to disease-free response and survival. High-dose DTIC plus actinomycin D is equally effective to BHD.