Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006462
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2000-11-06
Brief Title:
Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Gemcitabine NSC 613327 in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2014-02
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
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine
Assess the toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease histology acute lymphoblastic leukemia vs acute myelogenous leukemia
Patients receive gemcitabine IV over 6 hours weekly for 3 weeks Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 10-20 patients will be accrued for this study
Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine
Assess the toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease histology acute lymphoblastic leukemia vs acute myelogenous leukemia
Patients receive gemcitabine IV over 6 hours weekly for 3 weeks Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 10-20 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 |
|---|---|---|---|
| CDR0000068271 | OTHER | Clinical Trialsgov | None |
| COG-ADVL0022 | OTHER | None | None |
| CCG-A0999 | OTHER | None | None |