Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003745
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Continuous 21 Day Infusion of Topotecan NSC 609699 in Children With Relapsed Solid Tumors
Status:
COMPLETED
Status Verified Date:
2003-04
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:
Phase II trial to study the effectiveness of topotecan in treating children who have recurrent relapsed or refractory sarcoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate in children with recurrent or refractory brain tumors sarcomas or neuroblastomas treated with topotecan Brain tumor and neuroblastoma strata closed to accrual effective 07022001 II Assess the toxicity of this regimen in a larger group of patients treated at the currently defined maximum tolerated dose
OUTLINE This is a multicenter study
Patients receive topotecan IV continuously on days 1-21 Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months
I Determine the response rate in children with recurrent or refractory brain tumors sarcomas or neuroblastomas treated with topotecan Brain tumor and neuroblastoma strata closed to accrual effective 07022001 II Assess the toxicity of this regimen in a larger group of patients treated at the currently defined maximum tolerated dose
OUTLINE This is a multicenter study
Patients receive topotecan IV continuously on days 1-21 Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months
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 |
|---|---|---|---|
| CDR0000066864 | REGISTRY | PDQ Physician Data Query | None |
| COG-A09713 | None | None | None |
| CCG-A09713 | None | None | None |
| CCG-09713 | None | None | None |