Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003616
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase III Trial of Irinotecan CPT-11 in Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2018-06
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 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 who have progressive or recurrent malignant glioma
PURPOSE Phase III trial to study the effectiveness of irinotecan in treating patients who have progressive or recurrent malignant glioma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and the dose limiting toxicities of irinotecan in patients with progressive or recurrent malignant glioma II Define the safety profile of every 3 week dosing of irinotecan in these patients III Characterize the pharmacokinetic profile of this regimen in these patients IV Assess evidence of antitumor activity in these patients V Determine the efficacy of irinotecan in these patients as measured by 6 month progression-free survival and objective tumor response VI Evaluate further the safety profile of irinotecan in these patients during phase II study
OUTLINE This is a dose escalation study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs EIAEDsyes vs no Group A without EIAEDs Patients receive irinotecan IV over 90 minutes on day 1 followed by up to 3 weeks of rest Group B with EIAEDs Patients receive the same treatment but dose escalation is performed in cohorts of 3 patients The maximum tolerated dose MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicities The Phase I MTD is the starting dose recommended for use in the Phase II portion of the study Treatment continues every 3 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year then every 6 months until disease progression Patients are then followed every 4 months for survival
PROJECTED ACCRUAL Up to 30 patients will be accrued for phase I within 10 months A total of 48 patients will be accrued for phase II within 6-8 months
OUTLINE This is a dose escalation study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs EIAEDsyes vs no Group A without EIAEDs Patients receive irinotecan IV over 90 minutes on day 1 followed by up to 3 weeks of rest Group B with EIAEDs Patients receive the same treatment but dose escalation is performed in cohorts of 3 patients The maximum tolerated dose MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicities The Phase I MTD is the starting dose recommended for use in the Phase II portion of the study Treatment continues every 3 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year then every 6 months until disease progression Patients are then followed every 4 months for survival
PROJECTED ACCRUAL Up to 30 patients will be accrued for phase I within 10 months A total of 48 patients will be accrued for phase II within 6-8 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| CDR0000066694 | REGISTRY | PDQ Physician Data Query | None |