Dose escalation trial of cyclophosphamide with Sargramostim in the treatment of central nervous system (CNS) neoplasms

Med Pediatr Oncol. 1995 Apr;24(4):241-7. doi: 10.1002/mpo.2950240406.

Abstract

We conducted a dose escalation trial of cyclophosphamide plus Sargramostim in the therapy of patients with newly diagnosed or recurrent central nervous system tumors. Cyclophosphamide was administered at doses ranging between 1.0 and 2.5 g/m2 daily for two doses. Sargramostim was administered at a fixed dose of 250 micrograms/m2 subcutaneously twice a day beginning 24 hours after the second cyclophosphamide dose and continuing through the leukocyte nadir until the absolute neutrophil count (ANC) was > 1,000 cells/microliters for two consecutive days. The MTD for patients who had not received any prior chemotherapy and who had received either no radiotherapy or radiotherapy confined to the cranium was 2.0 g/m2 daily for two doses. The MTD for patients previously treated with chemotherapy or neuraxis radiotherapy was also 2.0 g/m2 daily for two doses. Responses were seen in patients with medulloblastoma (8/9), glioblastoma multiforme (2/13), germinoma (1/1), and pineoblastoma (1/2).

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Adult
  • Brain Neoplasms / drug therapy*
  • Child
  • Child, Preschool
  • Cyclophosphamide / administration & dosage*
  • Cyclophosphamide / adverse effects
  • Dose-Response Relationship, Drug
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor* / administration & dosage*
  • Granulocyte-Macrophage Colony-Stimulating Factor* / adverse effects
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Neutropenia / prevention & control*
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects

Substances

  • Recombinant Proteins
  • sargramostim
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Cyclophosphamide