Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003735
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Children With Relapsed Acute Leukemia Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2014-07
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of topotecan in treating children who have relapsed acute leukemia acute myeloid leukemia or blast phase chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of topotecan in treating children who have relapsed acute leukemia acute myeloid leukemia or blast phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the response rate of patients with relapsed acute lymphocytic leukemia acute myeloid leukemia or blastic phase chronic myelogenous leukemia treated with oral topotecan II Determine the toxic effects and pharmacokinetics of this regimen in these patients
OUTLINE Patients are stratified by disease type acute lymphocytic leukemia vs acute myeloid leukemia Patients receive oral topotecan once daily on days 1-21 Courses repeat every 28 days in the absence of blasts in the blood M3 bone marrow or unacceptable toxicity Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study within 2 years
OUTLINE Patients are stratified by disease type acute lymphocytic leukemia vs acute myeloid leukemia Patients receive oral topotecan once daily on days 1-21 Courses repeat every 28 days in the absence of blasts in the blood M3 bone marrow or unacceptable toxicity Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study within 2 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 |
|---|---|---|---|
| COG-09714 | OTHER | Childrens Oncology Group | None |
| CCG-09714 | None | None | None |
| CDR0000066850 | None | None | None |