High-Dose Cyclophosphamide for Steroid Refractory GVHD

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute graft-versus-host disease (GVHD) ≥ clinical grade II, that is steroid refractory

• Steroid refractory GVHD is defined as GVHD that has progressed (increasing in grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg OR GVHD that has failed to improve (no change in grading stage) despite 4 days of treatment with methylprednisolone of ≥ 2.0 mg/kg

• Prior allogeneic hematopoietic stem cell transplantation using either bone marrow, peripheral blood stem cells, or cord blood OR prior donor lymphocyte infusion required

• Evidence of myeloid engraftment

• No chronic GVHD

PATIENT CHARACTERISTICS:

• ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2 OR Karnofsky PS 60-100%

• ANC (absolute neutrophil count) > 500/mm³

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Must be geographically accessible

• No allergy or intolerance to cyclophosphamide or mesna

• No HIV positivity

• No mechanical ventilation

• No active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic cystitis

• No other uncontrolled illness including, but not limited to, the following:

• Ongoing or active infection

• Medical condition precluding patient from stopping azoles (e.g., fluconazole, itraconazole, or voriconazole) or other adequate antifungal therapy during cyclophosphamide administration

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Psychiatric illness/social situations that would preclude compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics