Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021242
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
2001-07-11
Brief Title:
Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Docetaxel Taxotere NSC 628503 IND 59761 in Children With Refractory Leukemias
Status:
COMPLETED
Status Verified Date:
2014-08
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 such as docetaxel work in different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive docetaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 10-20 patients will be accrued for this study within 1 year
Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive docetaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 10-20 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000068762 | OTHER | Clinical Trialsgov | None |
| COG-ADVL0023 | OTHER | None | None |
| CCG-09715 | OTHER | None | None |