High-Dose Cyclophosphamide in Treating Patients With Acute Graft-Versus-Host Disease That Did Not Respond to Steroid Therapy
RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute graft-versus-host disease that did not respond to steroid therapy.
PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose cyclophosphamide works in treating patients with acute graft-versus-host disease that did not respond to steroid therapy.
|Graft Versus Host Disease||Biological: filgrastim Drug: cyclophosphamide||Phase 2|
|Study Design:||Primary Purpose: Supportive Care|
- Maximum tolerated dose of high-dose cyclophosphamide
|Study Start Date:||May 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
- 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 counts recover.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492921
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Javier Bolanos-Meade, MD||Sidney Kimmel Comprehensive Cancer Center|