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Clinical Phase I Study of Aclacinomycin A by Evaluation of an Intermittent Intravenous Administration Schedule¹

Developmental Chemotherapy Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, New York 10021

Aclacinomycin A (ACM) is an anthracycline antibiotic recently introduced into clinical trials because of its reduced cardiac toxicity in animal models relative to Adriamycin and daunomycin. This Phase I study of ACM was conducted to determine a dose suitable for i.v. administration on an every-3-week schedule. Twenty-five adult patients with solid tumors were treated with doses of ACM ranging from 60 to 120 mg/sq m i.v. every 3 to 4 weeks. Myelosuppression was the dose-limiting toxicity, but the degree and timing of blood count depression were variable at each dose level. Nausea and vomiting were seen at myelosuppressive doses, but mucositis was rare. Alopecia was seen in approximately one-third of the patients. There was no acute cardiac toxicity, but cumulative cardiac injury could not be evaluated in this trial. There were no major objective responses in three patients who had measurable disease. The recommended doses of ACM for Phase II studies are 100 mg/sq m for good-risk patients and 80 mg/sq m for patients who are heavily pretreated or who have a poor performance status.

¹ This investigation was supported in part by Contract N01-CM97274 from the Division of Cancer Treatment and USPHS Grant CA 05826 from the National Cancer Institute, NIH, Bethesda, Md.

² Recipient of an American Cancer Society Junior Faculty Fellowship.

³ To whom requests for reprints should be addressed, at Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, N. Y. 10021.

Received 1/ 7/81. Accepted 3/13/81.

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