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

NCT00004194 | Unknown Phase 1

• 3 other identifiers: CDR0000067435UCLA-9701029NCI-G99-1650
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Graft Versus Host Disease

Keywords

graft versus host disease

Interventions

fludarabine phosphate DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

fludarabine phosphate

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Christos E. Emmanouilides, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: September 16, 2004
• Last Updated: December 18, 2013

Record last verified: 2000-04