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Related Experiment Videos

Phase I study of L-alanosine (NSC 15353).

M A Goldsmith, T Ohnuma, M Spigelman

    Cancer
    |February 1, 1983
    PubMed
    Summary

    L-alanosine, an antitumor antibiotic, inhibits purine metabolism and showed activity in murine tumors. Phase I trials identified oral mucositis as a dose-limiting toxicity, establishing a recommended Phase II dose.

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    Area of Science:

    • Pharmacology and Experimental Therapeutics
    • Oncology
    • Drug Metabolism

    Background:

    • L-alanosine (NSC 15353) is a novel antibiotic with antitumor properties.
    • It functions by inhibiting crucial purine intermediary metabolism pathways.
    • Preclinical studies indicated potential efficacy across various murine neoplasms.

    Purpose of the Study:

    • To evaluate the safety and tolerability of L-alanosine in a Phase I clinical trial.
    • To determine the maximum tolerated dose (MTD) and recommended dose for further studies.
    • To assess the dose-limiting toxicities associated with L-alanosine administration.

    Main Methods:

    • A Phase I clinical trial was conducted using a daily x 5 (d x 5) dosing schedule.
    • Twenty-two evaluable patients were enrolled in the study.
    • Dose escalation was performed to identify the MTD and establish the recommended dose for Phase II.

    Main Results:

    • The primary dose-limiting toxicity observed was oral mucositis, presenting as significant erythema.
    • The maximum tolerated dose (MTD) was determined to be 320 mg/m²/day for 5 consecutive days every three weeks.
    • The recommended dose for Phase II evaluation was established at 160 mg/m²/day for 5 consecutive days every three weeks.

    Conclusions:

    • L-alanosine demonstrates antitumor potential through purine metabolism inhibition.
    • Oral mucositis is a key toxicity requiring careful monitoring.
    • The recommended dose of 160 mg/m²/day x 5 q3w is suitable for Phase II trials.

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