- Determine the maximum tolerated dose of high-dose cyclophosphamide in patients with
steroid refractory acute graft-versus-host disease.
- Determine the efficacy of this regimen at 28 days post-treatment in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive high-dose cyclophosphamide once daily for 1-4 days beginning on day 1 and
filgrastim (G-CSF) subcutaneously once daily beginning on day 10 and continuing until blood
Cohorts of 3-6 patients receive escalating doses of high-dose cyclophosphamide until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed weekly for 4 weeks.
Primary Purpose: Supportive Care
Maximum tolerated dose of high-dose cyclophosphamide
Javier Bolanos-Meade, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|