Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia
Recruitment status was: Active, not recruiting
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.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||April 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006127
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||W. Nicholas Haining||Dana-Farber Cancer Institute|