Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003372
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
1999-11-01
Brief Title:
Topotecan in Treating Patients With Recurrent Brain Tumors
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma
Status:
COMPLETED
Status Verified Date:
2020-04
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:
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 topotecan in treating patients with recurrent brain tumor
PURPOSE Phase II trial to study the effectiveness of topotecan in treating patients with recurrent brain tumor
Detailed Description:
OBJECTIVES I Determine the efficacy of topotecan in patients with recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma II Determine the qualitative and quantitative toxicity of topotecan in this patient population on this schedule
OUTLINE This is a multicenter study Patients receive intravenous topotecan over 30 minutes daily for 5 days every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients will be followed every 3 months until death
PROJECTED ACCRUAL Up to 30 evaluable patients will be accrued within 2-3 years
OUTLINE This is a multicenter study Patients receive intravenous topotecan over 30 minutes daily for 5 days every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients will be followed every 3 months until death
PROJECTED ACCRUAL Up to 30 evaluable patients will be accrued within 2-3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000066362 | OTHER | PDQ | None |
| CAN-NCIC-IND109 | OTHER | None | None |