Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia
|ClinicalTrials.gov Identifier: NCT00006127|
Recruitment Status : Unknown
Verified October 2003 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Fanconi's Anemia||Drug: amifostine||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||21 participants|
|Study Start Date :||April 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006127
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||W. Nicholas Haining||Dana-Farber Cancer Institute|