Fludarabine in Treating Patients With Steroid-Resistant Chronic Graft- Versus-Host Disease
NCT ID: NCT00004194
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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OUTLINE: This is a dose escalation study. Phase I: Patients receive fludarabine IV over less than 30 minutes for 1-3 days. Treatment repeats every 4 weeks for up to 4 courses in the absence of relapse of underlying disease, malignancy, graft rejection, or unacceptable toxicity. Patients with progressive graft versus host disease after completion of 3 courses are taken off study. Patients with complete response are taken off study. Patients with partial response may continue treatment at the immediate prior dose level. Cohorts 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity. Phase II: Patients receive fludarabine at the MTD from phase I of the study.
PROJECTED ACCRUAL: A total of 15-27 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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SUPPORTIVE_CARE
Interventions
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fludarabine phosphate
Eligibility Criteria
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Inclusion Criteria
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)
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Principal Investigators
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Christos E. Emmanouilides, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Other Identifiers
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UCLA-9701029
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1650
Identifier Type: -
Identifier Source: secondary_id
CDR0000067435
Identifier Type: -
Identifier Source: org_study_id