PHASE-I-II STUDY OF INTERMITTENT BOLUS ADMINISTRATION OF DTIC AND ACTINOMYCIN-D IN METASTATIC MALIGNANT-MELANOMA

Abstract

Patients [26] with disseminated malignant melanoma were treated with intermittent bolus DTIC [Dacarbazine] and actinomycin D in an escalating dose schedule, starting at 650 and 1 mg/m2, respectively, Courses were repeated at 3-4 wk intervals. Patients (24) were evaluable for toxicity and 22 were evaluable for response. Two patients (9%) had a complete remission lasting 7 and 14 mo., and 3 patients (14%) had a partial remission lasting 2, 5 and 14 mo. Nausea and vomiting, lasting 24 h, was observed in 88% of patients, while diarrhea was noted in 17%. Stomatitis and alopecia were less frequently observed. All responses occurred at nonmyelosuppressive doses and in patients with visceral-predominant metastases. This schedule offered the patient the convenience of single-day treatment and less prolonged gastrointestinal intolerance. Further evaluation of this drug combination and schedule would appear to be indicated.