Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003301
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Recurrent Malignant Glioma
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose Finding and SafetyEfficacy Trial of CPT-11 Irinotecan in Patients With Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2005-09
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 III trial to study the effectiveness of irinotecan in treating patients with recurrent malignant glioma
PURPOSE Phase III trial to study the effectiveness of irinotecan in treating patients with recurrent malignant glioma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of intravenous irinotecan when administered weekly for 4 weeks in patients with recurrent malignant gliomas II Describe the pharmacokinetics of this route of administration measuring both irinotecan and the active metabolite SN-38 and determine the effects of hepatic enzyme inducing drugs such as anticonvulsants on the pharmacokinetics in these patients III Determine preliminary response data and activity of irinotecan in this patient population IV Correlate response with topoisomerase I levels in brain tumor tissue from patients undergoing treatment
OUTLINE Patients are stratified based on their usekind of anticonvulsant drugs This stratification yields two arms for this study Arm I consists of patients who use anticonvulsant drugs that induce hepatic metabolic enzymes Arm II consists of patients who use anticonvulsant drugs that cause modest to no induction of hepatic metabolic enzymes or no anticonvulsant drug Three patients in each arm receive irinotecan by 90-minute IV infusions every week for 4 weeks followed by a 2 week rest period The dose is escalated for the next cohort of 3 patients in the absence of unacceptable dose limiting toxicity The 6 week course is repeated until unacceptable toxicity or disease progression Once the maximum tolerated dose has been established for each arm additional patients are treated at that dose level Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 3 patients will be accrued into the phase I portion of the study and a total of 18-35 patients will be accrued into each arm of the phase II portion of the study
OUTLINE Patients are stratified based on their usekind of anticonvulsant drugs This stratification yields two arms for this study Arm I consists of patients who use anticonvulsant drugs that induce hepatic metabolic enzymes Arm II consists of patients who use anticonvulsant drugs that cause modest to no induction of hepatic metabolic enzymes or no anticonvulsant drug Three patients in each arm receive irinotecan by 90-minute IV infusions every week for 4 weeks followed by a 2 week rest period The dose is escalated for the next cohort of 3 patients in the absence of unacceptable dose limiting toxicity The 6 week course is repeated until unacceptable toxicity or disease progression Once the maximum tolerated dose has been established for each arm additional patients are treated at that dose level Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 3 patients will be accrued into the phase I portion of the study and a total of 18-35 patients will be accrued into each arm of the phase II portion of the 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 |
|---|---|---|---|
| JHOC-NABTT-9711 | None | None | None |
| NABTT-9711 | None | None | None |