Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470275
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2007-05-03
Brief Title:
Cytarabine in Treating Young Patients With Recurrent or Refractory Ewings Sarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWSFLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma
Status:
COMPLETED
Status Verified Date:
2014-10
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 cytarabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewings sarcoma
PURPOSE This phase II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewings sarcoma
Detailed Description:
OBJECTIVES
Determine the response rate in younger patients with recurrent or refractory Ewings sarcoma treated with cytarabine
OUTLINE This is a multicenter study
Patients receive cytarabine IV over 2 hours twice daily on days 1-5 Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the response rate in younger patients with recurrent or refractory Ewings sarcoma treated with cytarabine
OUTLINE This is a multicenter study
Patients receive cytarabine IV over 2 hours twice daily on days 1-5 Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 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 |
|---|---|---|---|
| COG-AEWS0621 | OTHER | Childrens Oncology Group | None |
| CDR0000542650 | OTHER | None | None |