Aclacinomycin A. Phase II evaluation in advanced soft tissue sarcoma

Aclacinomycin A (ACLA-A), an anthracycline antibiotic, was administered in a Phase II study to 20 patients with advanced, measurable soft tissue sarcomas. The dose schedule consisted of 85 mg/m2 intravenous ACLA-A given weekly for 4 weeks followed by a 2-week rest. Because of severe myelosuppression in the initial patients, the weekly dose was reduced to 65 mg/m2. Seventeen patients were fully evaluable for toxicity and response to the drug. Complete or partial responses were not identified. Toxicity was primarily hematological. ACLA-A administered in the above schedule demonstrated no therapeutic efficacy in patients with advanced soft tissue sarcomas.