Trials / Unknown
UnknownNCT00006127
Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (planned)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | amifostine |
Timeline
- Start date
- 2000-04-01
- First posted
- 2000-08-04
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00006127. Inclusion in this directory is not an endorsement.