Phase 1-11 study of DTIC and cyclocytidine in disseminated malignant melanoma

Seventeen patients with disseminated malignant melanoma were treated with DTIC (150 mg/m2, Days 1-5) and cyclocytidine (increasing doses sc, Days 1-10) in a phase I-II study. There was one early death. The remaining 16 patients were evaluable for response and toxicity. Two patients (13%) had CR lasting 8+ and 2+ months, while one patient (6%) had a PR lasting 1 month. Nausea and vomiting was seen in seven patients (44%), jaw pain in four (25%), and orthostatic hypotension in two (13%). Hematologic toxicity was not excessive, nor was it cumulative. The overall response rate of 19% was comparable to that reported with DTIC alone. This drug combination does not appear to offer any therapeutic advantage within the dosage range tested in disseminated malignant melanoma.