The report presents a preliminary analysis of a randomized clinical trial to determine whether the tested forms of immunotherapy or chemotherapy significantly improved the disease-free interval and survival of patients with localized or regional malignant melanoma. Patients with cutaneous Stage I and Stage II melanomas were randomized to receive either no further treatment, BCG alone, BCG plus neuraminidase-treated allogenic cells, or methyl-CCNU. There was a statistically significant improvement in disease-free interval or overall survival rate for any of the treatment arms when compared with the control arm. Prolonged patient followup will be necessary before a final statement can be made regarding the relative effectiveness of these treatment modalities.
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