Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003415
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
1999-11-01
Brief Title:
Amifostine Plus Topotecan in Treating Patients With Myelodysplastic Syndrome
Sponsor:
University of Arizona
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Combined Treatment With Amifostine Ethyol and Topotecan Hycamtin MS in Patients With Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of amifostine plus topotecan in treating patients with myelodysplastic syndrome
PURPOSE Phase III trial to study the effectiveness of amifostine plus topotecan in treating patients with myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Evaluate the hematologic and cytogenetic response to treatment with amifostine plus topotecan in patients with myelodysplastic syndromes II Evaluate the toxic effects of this treatment in these patients III Evaluate the effects of this treatment on bone marrow recovery in these patients
OUTLINE This is a dose escalation study of topotecan Patients receive amifostine IV followed by topotecan IV over 30 minutes on days 1-5 every 4-8 weeks for at least two courses Patients who are responding after two courses of induction receive maintenance courses every 6-8 weeks for up to ten courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at each dose level of topotecan The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A maximum of 26 patients will be accrued for this study
OUTLINE This is a dose escalation study of topotecan Patients receive amifostine IV followed by topotecan IV over 30 minutes on days 1-5 every 4-8 weeks for at least two courses Patients who are responding after two courses of induction receive maintenance courses every 6-8 weeks for up to ten courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at each dose level of topotecan The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A maximum of 26 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1454 | None | None | None |
| UARIZ-HSC-97148 | None | None | None |
| ALZA-97-017-ii | None | None | None |