Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006127
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Brief Title:
Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconis Anemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Evaluate the toxicity of amifostine in patients with bone marrow failure related to Fanconis 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
I Evaluate the toxicity of amifostine in patients with bone marrow failure related to Fanconis 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DFCI-9910170 | None | None | None |
| ALZA-99-004-ii | None | None | None |