Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia
NCT ID: NCT00006127
Last Updated: 2005-06-24
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
21 participants
INTERVENTIONAL
2000-04-30
Brief Summary
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I. Evaluate the toxicity of amifostine in patients with bone marrow failure related to Fanconi's anemia.
II. Determine the efficacy of this treatment regimen in this patient population.
III. Evaluate the effect of this treatment regimen on bone marrow progenitor cell proliferation and peripheral blood mononuclear cell apoptosis in these patients.
Detailed Description
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This is a dose escalation study.
Patients receive amifostine IV over 3-5 minutes three times a week for three weeks.
Cohorts of 3 patients receive one of three dose levels of amifostine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed weekly for 3 weeks.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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amifostine
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
Diagnosis of Fanconi's anemia by conventional diepoxybutane or mitomycin sensitivity assays, or molecular testing
Bone marrow failure verified on at least 3 occasions in the preceding 3 months by any one of the following: hemoglobin less than 8 g/dL; absolute neutrophil count less than 1,000/mm3; platelet count less than 30,000/mm3; symptomatic bone marrow failure (e.g., exercise limitation from anemia or spontaneous bleeding from thrombocytopenia)
Evidence consistent with myelodysplastic syndrome allowed if less than 5% blasts on bone marrow aspiration; clonality on bone marrow cytogenetic analysis OR morphological changes on bone marrow aspirate
Refusal of or unsuccessful with prior conventional therapies
--Prior/Concurrent Therapy--
Biologic therapy: No prior bone marrow transplantation; no concurrent hematopoietic growth factors
Endocrine therapy: No concurrent androgens
--Patient Characteristics--
Hepatic: Bilirubin no greater than 2 times normal AST no greater than 3 times normal ALT no greater than 6 times normal
Renal: Creatinine no greater than 2 times normal
Other: No prior malignancy; no active bacterial, viral, or fungal infection requiring therapy other than prophylaxis; not pregnant; negative pregnancy test
2 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Principal Investigators
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W. Nicholas Haining
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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DFCI-9910170
Identifier Type: -
Identifier Source: secondary_id
ALZA-99-004-ii
Identifier Type: -
Identifier Source: secondary_id
199/15281
Identifier Type: -
Identifier Source: org_study_id