High-Dose Cyclophosphamide in Treating Patients With Acute Graft-Versus-Host Disease That Did Not Respond to Steroid Therapy
|ClinicalTrials.gov Identifier: NCT00492921|
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : June 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Biological: filgrastim Drug: cyclophosphamide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Primary Purpose:||Supportive Care|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
- Maximum tolerated dose of high-dose cyclophosphamide
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|