Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003827
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
Sponsor:
ALZA
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine Topotecan and ARA-C A Phase II Study
Status:
UNKNOWN
Status Verified Date:
2007-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the toxic effects of amifostine topotecan and cytarabine in patients with poor risk myelodysplastic syndrome
Determine the hematologic response rate cytogenetic response rate and the rate of polyclonal hematopoiesis following this treatment regimen
Determine the duration of response and time to disease progression following this treatment regimen in these patients
OUTLINE Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours on days 1-5 Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days Patients may receive a second course of the same regimen 8 weeks after the first
Patients are followed at least monthly for 2 years then every 3-6 months until death
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study within 1 to 15 years
Determine the toxic effects of amifostine topotecan and cytarabine in patients with poor risk myelodysplastic syndrome
Determine the hematologic response rate cytogenetic response rate and the rate of polyclonal hematopoiesis following this treatment regimen
Determine the duration of response and time to disease progression following this treatment regimen in these patients
OUTLINE Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours on days 1-5 Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days Patients may receive a second course of the same regimen 8 weeks after the first
Patients are followed at least monthly for 2 years then every 3-6 months until death
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study within 1 to 15 years
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 |
|---|---|---|---|
| CHNMC-IRB-98056 | None | None | None |
| ALZA-CHNMC-IRB-98056 | None | None | None |
| NCI-V99-1533 | None | None | None |