Overview

Fludarabine in Treating Patients With Steroid-Resistant Chronic Graft- Versus-Host Disease

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Fludarabine may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation. PURPOSE: Phase I/II trial to study the effectiveness of fludarabine in treating patients who have chronic graft-versus-host disease that has not responded to steroid therapy.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Fludarabine
Fludarabine phosphate
Vidarabine
Criteria
DISEASE CHARACTERISTICS: Histologically or clinically proven chronic graft versus host
disease (GVHD) that has failed to respond to at least 1 month of treatment with the
following: Steroids (greater than 0.5 mg/kg/day) AND Cyclosporine or a cytotoxic agent
(azathioprine or mercaptopurine) OR Other experimental treatment (such as chloroquine) All
allogeneic bone marrow or peripheral blood stem cell transplantation patients eligible
regardless of underlying disease for which transplantation was performed if: At least 45
days since prior transplantation No relapse of underlying disease No loss of donor
hematopoiesis Patients with a rapid deterioration of GVHD that is considered life
threatening if not controlled are eligible after receiving high dose steroids (greater than
1 mg/kg/day) for at least 10 days

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,300/mm3
Platelet count at least 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than
2 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: No
other concurrent cytotoxic drugs Endocrine therapy: Concurrent steroids allowed but must be
tapered to less than 0.5 mg/kg/day of prednisone or equivalent prior to starting study drug
(if symptomatic flare develops during taper, patients may continue on the lowest dose
thought to produce stabilization) Radiotherapy: Not specified Surgery: Not specified Other:
Concurrent cyclosporine and other nonmyelosuppressive drugs allowed No concurrent
myelosuppressive agents (azathioprine, mercaptopurine)