NCT00492921

High-Dose Cyclophosphamide for Steroid Refractory GVHD

High-Dose Cyclophosphamide in Treating Patients With Acute Graft-Versus-Host Disease That Did Not Respond to Steroid Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of high-dose cyclophosphamide in patients with steroid refractory acute graft-versus-host disease (GVHD). * 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.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Cyclophosphamide

Timeline

• Start date: 2007-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2007-06-27
• Last updated: 2018-09-14
• Results posted: 2018-09-14

Locations

1 site across 1 country: United States