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Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia

Fanconi's Anemia Clinical Trial

Clinical Trial Summary

OBJECTIVES:

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.

Clinical Trial Description

PROTOCOL OUTLINE:

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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00006127
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 2000
View Details
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