Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006025
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2000-07-05
Brief Title:
Temozolomide Plus Irinotecan in Treating Patients With 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 I-II Trial of CPT-11 and Temozolomide Temodar 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 Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma
PURPOSE Phase III trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan when administered with temozolomide in patients with recurrent malignant glioma
Determine the safety profile of this regimen in this patient population
Determine the efficacy of this treatment regimen as measured by 6-month progression-free survival and objective tumor response in these patients
Characterize the pharmacokinetics of this treatment regimen in these patients
Determine the antitumor activity of this treatment regimen in these patients
OUTLINE This is a multicenter dose-escalation study of irinotecan Patients are stratified according to concurrent enzyme-inducing anti-epileptic drugs EIAEDs eg phenytoin phenobarbital carbamazepine or primidone yes vs no
In phase I of the study patients receive oral temozolomide on days 1-5 and irinotecan IV over 90 minutes on days 1 and 14 Treatment continues every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients concurrently on EIAEDs undergo dose escalation of irinotecan Cohorts of 3 to 6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
In phase II of the study patients receive the same treatment as in phase I at the MTD
Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year every 6 months until progression and then every 4 months for survival
PROJECTED ACCRUAL A total of 30 patients will be accrued for phase I within 10 months and 48 patients will be accrued for phase II within 6-8 months
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan when administered with temozolomide in patients with recurrent malignant glioma
Determine the safety profile of this regimen in this patient population
Determine the efficacy of this treatment regimen as measured by 6-month progression-free survival and objective tumor response in these patients
Characterize the pharmacokinetics of this treatment regimen in these patients
Determine the antitumor activity of this treatment regimen in these patients
OUTLINE This is a multicenter dose-escalation study of irinotecan Patients are stratified according to concurrent enzyme-inducing anti-epileptic drugs EIAEDs eg phenytoin phenobarbital carbamazepine or primidone yes vs no
In phase I of the study patients receive oral temozolomide on days 1-5 and irinotecan IV over 90 minutes on days 1 and 14 Treatment continues every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients concurrently on EIAEDs undergo dose escalation of irinotecan Cohorts of 3 to 6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
In phase II of the study patients receive the same treatment as in phase I at the MTD
Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year every 6 months until progression and then every 4 months for survival
PROJECTED ACCRUAL A total of 30 patients will be accrued for phase I within 10 months and 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 |
|---|---|---|---|
| NCI-2012-02353 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| CDR0000068037 | REGISTRY | None | None |
| UCLA-0006095 | None | None | None |