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Phase I trial of aclacinomycin A
Cancer Treatment Reports
|May 1, 1982
Summary
Aclacinomycin A (ACM-A) showed dose-limiting myelosuppression and cardiac rhythm disturbances in a phase I trial. No antitumor responses were observed, suggesting limited efficacy for solid tumors.
Area of Science:
- Oncology
- Pharmacology
- Cardiology
Background:
- Aclacinomycin A (ACM-A) is an anthracycline analog investigated for its therapeutic potential.
- Phase I clinical trials are crucial for evaluating the safety and dosage of novel cancer therapeutics.
Purpose of the Study:
- To assess the safety, tolerability, and preliminary efficacy of Aclacinomycin A (ACM-A) in patients with solid tumors and multiple myeloma.
- To determine the dose-limiting toxicities and establish recommended dosages for phase II studies.
Main Methods:
- A phase I clinical trial administered Aclacinomycin A (ACM-A) at doses ranging from 60-120 mg/m2 every 3 weeks.
- Toxicity was monitored, including myelosuppression and cardiac function via 24-hour ECG (Holter) recordings.
- Antitumor responses were assessed in patients with measurable disease.
Main Results:
- Dose-limiting toxicity was myelosuppression, particularly thrombocytopenia, and variable granulocytopenia.
- Increased premature atrial and ventricular beats were observed; one patient experienced high-degree atrioventricular and complete heart block.
- No antitumor responses were observed in patients receiving two or more courses of ACM-A.
Conclusions:
- Recommended phase II doses are 100 mg/m2 every 4 weeks for high-performance status patients and 60 mg/m2 every 4 weeks for others.
- Due to acute cardiac effects, continuous ECG monitoring is recommended during Aclacinomycin A (ACM-A) treatment.