SWOG 8825: Melphalan GM-CSF: A phase I study

Elizabeth Poplin, Harriet Smith, Brent Behrens, Bruce Redman, Lawrence Flaherty, James Neidhart, David Alberts

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

The use of intravenous melphalan at higher doses is limited by severe myelosuppression. It was postulated that GM-CSF would permit the use of higher dose melphalan with only moderate myelosuppression easily manageable in an outpatient setting. Therefore, a phase I study of intravenous melphalan utilizing GM-CSF (recombinant granulocyte-macrophage colony-stimulating factor) support was initiated. Intravenous melphalan at doses of 15-45 mg/m2 was administered every 28 days. GM-CSF was utilized at doses of 10-20 μg/kg/day subcutaneously Days 2-21 on a 28-day cycle. Twenty-five patients received 53 courses of therapy. The dose-limiting toxicities were severe or life-threatening granulocytopenia and thrombocytopenia. Utilizing 20 μg/kg/day GM-CSF, the maximum tolerated dose (MTD) of melphalan is 30 mg/m2 and, with 10 mg/kg/day GM-CSF, the maximum tolerated melphalan dose is only 20 mg/m2. One patient with ovarian cancer achieved a partial response. Because the reported MTD of intravenous melphalan without GM-CSF is 30 mg/m2, GM-CSF has not allowed sufficient escalation of the intravenous melphalan dose for routine outpatient use.

Original languageEnglish (US)
Pages (from-to)66-70
Number of pages5
JournalGynecologic Oncology
Volume44
Issue number1
DOIs
StatePublished - Jan 1992

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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    Poplin, E., Smith, H., Behrens, B., Redman, B., Flaherty, L., Neidhart, J., & Alberts, D. (1992). SWOG 8825: Melphalan GM-CSF: A phase I study. Gynecologic Oncology, 44(1), 66-70. https://doi.org/10.1016/0090-8258(92)90014-A