Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276692
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2006-01-12
Brief Title:
Irinotecan in Treating Patients With Newly Diagnosed Ewings Sarcoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Irinotecan CPT-11 in Children and Adolescents With High Risk Ewings Sarcoma
Status:
COMPLETED
Status Verified Date:
2009-06
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 irinotecan 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 irinotecan works in treating patients with newly diagnosed Ewings sarcoma
PURPOSE This phase II trial is studying how well irinotecan works in treating patients with newly diagnosed Ewings sarcoma
Detailed Description:
OBJECTIVES
Primary
Assess the responsiveness of single-agent irinotecan hydrochloride in a patient population with newly diagnosed high-risk Ewings sarcoma
OUTLINE This is an open-label multicenter study
Patients receive irinotecan hydrochloride IV over 1 hour on day 1 Treatment repeats every 21 days for 2 courses After completion of 2 courses of therapy patients may receive additional treatment at the discretion of the treating physician
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Assess the responsiveness of single-agent irinotecan hydrochloride in a patient population with newly diagnosed high-risk Ewings sarcoma
OUTLINE This is an open-label multicenter study
Patients receive irinotecan hydrochloride IV over 1 hour on day 1 Treatment repeats every 21 days for 2 courses After completion of 2 courses of therapy patients may receive additional treatment at the discretion of the treating physician
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20582 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000454550 | REGISTRY | None | None |