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Early clinical trial with quelamycin.

H Cortés-Funes, M Gosálvez, A Moyano

    Cancer Treatment Reports
    |May 1, 1979
    PubMed
    Summary
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    Quelamycin, a novel Adriamycin derivative, shows antitumor effects in various solid tumors. The recommended dose is 150 mg/m2, with myelosuppression as the main dose-limiting toxicity.

    Area of Science:

    • Oncology
    • Pharmacology

    Background:

    • Quelamycin (triferric doxorubicin) is a novel Adriamycin derivative with distinct pharmacologic properties.
    • Adriamycin derivatives are critical in cancer chemotherapy.

    Purpose of the Study:

    • To evaluate the safety and efficacy of quelamycin in a Phase I clinical trial.
    • To determine the recommended dosage and identify dose-limiting toxicities of quelamycin.

    Main Methods:

    • A Phase I clinical study involving 37 patients with diverse solid tumors.
    • Administered quelamycin as a 1-hour infusion every 3 weeks.
    • Monitored for adverse events, antitumor responses, and determined the maximum tolerated dose.

    Main Results:

    • The recommended dose for good-risk patients is 150 mg/m2 every 3 weeks.

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  • Myelosuppression, particularly leukopenia, was the primary dose-limiting toxicity.
  • Observed objective antitumor effects in lung, gastric, colon, ovarian carcinomas, and osteogenic sarcoma.
  • Common toxicities included gastrointestinal intolerance, alopecia, chills, and fever.

    • Conclusions:

    • Quelamycin demonstrates potential antitumor activity across a range of solid tumors.
    • Further investigation with improved pharmaceutical formulations is warranted.
    • Myelosuppression and gastrointestinal issues necessitate careful patient monitoring and dose adjustments.