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Related Experiment Videos

SWOG 8825: melphalan GM-CSF: a phase I study.

E Poplin1, H Smith, B Behrens

  • 1Wayne State University Medical Center, Detroit, Michigan 48201.

Gynecologic Oncology
|January 1, 1992
PubMed
Summary

This study investigated if granulocyte-macrophage colony-stimulating factor (GM-CSF) could enable higher doses of intravenous melphalan. Results indicate GM-CSF did not significantly increase the melphalan dose-limiting toxicity threshold for outpatient use.

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Area of Science:

  • Oncology
  • Pharmacology
  • Hematology

Background:

  • High-dose intravenous melphalan is limited by severe myelosuppression.
  • Granulocyte-macrophage colony-stimulating factor (GM-CSF) was hypothesized to mitigate melphalan-induced myelosuppression.
  • This could allow for higher melphalan doses in an outpatient setting.

Purpose of the Study:

  • To conduct a phase I study evaluating the safety and tolerability of intravenous melphalan with GM-CSF support.
  • To determine the maximum tolerated dose (MTD) of melphalan when administered with GM-CSF.
  • To assess the feasibility of outpatient administration.

Main Methods:

  • A phase I study administered intravenous melphalan (15-45 mg/m2) every 28 days.
  • GM-CSF (10-20 micrograms/kg/day subcutaneously) was given on Days 2-21 of each cycle.

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  • Twenty-five patients received 53 courses of therapy.

    • Main Results:

    • Dose-limiting toxicities included severe granulocytopenia and thrombocytopenia.
    • With 20 micrograms/kg/day GM-CSF, the MTD of melphalan was 30 mg/m2.
    • With 10 micrograms/kg/day GM-CSF, the MTD of melphalan was 20 mg/m2.
    • One patient with ovarian cancer achieved a partial response.

    Conclusions:

    • GM-CSF did not allow for a significant escalation of the intravenous melphalan MTD compared to historical data without GM-CSF.
    • The MTD of intravenous melphalan with GM-CSF support was found to be 30 mg/m2.
    • GM-CSF did not facilitate routine outpatient use of higher-dose melphalan due to dose-limiting toxicities.