Phase II study of tauromustine in disseminated malignant melanoma

Forty-seven patients with metastatic malignant melanoma took part in a phase II trial of tauromustine (TCNU), a new chlorethylnitrosourea based on the endogenous amino acid taurine. TCNU was given orally at a dosage of 130 mg/m2 every fifth week. No patient had previously received cytotoxic therapy. Among 37 evaluable patients, 26 patients experienced progressive disease including seven patients with early death, five showed no change, and six partial responses, yielding an objective response rate of 16%. Responses were limited to subcutaneous, lymph node, bone and lung metastases. Median time to progression was 26 weeks for responders. The treatment schedule was well tolerated with a median dose of 88% of the predicted dose given during all cycles. Dose-limiting toxicity was thrombocytopenia. It appears that TCNU is active in disseminated malignant melanoma with a response rate similar to other nitrosoureas.