Clinical study of aclacinomycin A

A phase I study of a new anthracycline antibiotic, aclacinomycin A, was performed in a total of 15 patients with advanced malignancy to determine the maximum-tolerated dose. The gastrointestinal toxicity which occurred was not dose-related and was not severe. Epilation and stomatitis were extremely minimal. Both hepatic dysfunction and hematologic toxicity were dose-limiting. A recommended dose for phase II study was determined to be 2.5--3.0 mg/kg (approximately 100--120 mg/m2) given in 3-week intervals. Objective response was observed in two patients with malignant lymphomas.