Results of a phase II trial with cystemustine at 90 mg/m(2) as a first- orsecond-line treatment in advanced malignant melanoma: a trial of the EORTCClinical Studies Group

From May 1991 to January 1996, 54 patients with advanced malignant melanoma were enrolled into a phase II trial testing the new nitrosourea cystemusti ne, administrated intravenously as a 15 min infusion every 2 weeks at 90 mg /m(2) for three cycles followed by 60 mg/m(2). Out of the 54 enrolled patie nts, 10 were ineligible, leaving 44 fully evaluable patients (World Health Organization criteria). Twenty one patients had already received first-line palliative chemotherapy and/or immunotherapy, The median age was 62 years (range 30-74 years) and the median performance status was 0 (grade 0, 19 pa tients; grade 1, 21 patients; grade 2, 4 patients). Five patients with part ial responses (lasting 16-29 weeks, mean duration 24 weeks), nine with stab le disease and 28 showing progression were observed, giving an overall resp onse rate of 11% (confidence interval 3.8-24.6%). Toxicity was mild and con sisted mainly of neutropenia (39% grade III-IV), thrombocytopenia (42% grad e III-IV); febrile aplasia was rare. Cystemustine administered to this sche dule appears to have limited clinical activity and acceptable toxicity in u ntreated or second-line advanced malignant melanoma. (C) 1999 Lippincott Wi lliams & Wilkins.