Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010049
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2001-02-02
Brief Title:
Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
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 STI571 NSC 716051 in Patients With Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma
PURPOSE Phase III trial to study the effectiveness of imatinib mesylate in treating patients who have progressive recurrent or unresectable malignant glioma or meningioma
PURPOSE Phase III trial to study the effectiveness of imatinib mesylate in treating patients who have progressive recurrent or unresectable malignant glioma or meningioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent malignant glioma or meningioma
Determine the safety profile of this drug in these patients
Determine the pharmacokinetics of this drug with or without concurrent enzyme-inducing anti-epileptic drugs EIAEDs in these patients Stratum of patients currently taking EIAEDs closed to accrual as of 05152003 for phase I and phase II
Determine angiogenic activity in vivo using functional neuro-imaging studies and in vitro with assays of serum angiogenic peptides
Determine the efficacy of this drug in terms of 6-month progression-free survival and objective tumor response in these patients
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use yes stratum closed to accrual as of 05152003 for phase I and phase II vs no
Phase I patients with glioma or meningioma Patients in cohorts 1 and 2 receive oral imatinib mesylate STI571 once daily on days 1-28 Patients in cohorts 3-5 receive oral STI571 twice daily on days 1 and 3-28 of the first course and on days 1-28 of subsequent courses Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II patients with glioma glioblastoma multiforme patients excluded as of 05152003 Patients receive oral STI571 at the MTD determined in phase I 1-2 times daily for 4 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months Glioblastoma multiforme patients excluded from phase II as of 05132003
Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent malignant glioma or meningioma
Determine the safety profile of this drug in these patients
Determine the pharmacokinetics of this drug with or without concurrent enzyme-inducing anti-epileptic drugs EIAEDs in these patients Stratum of patients currently taking EIAEDs closed to accrual as of 05152003 for phase I and phase II
Determine angiogenic activity in vivo using functional neuro-imaging studies and in vitro with assays of serum angiogenic peptides
Determine the efficacy of this drug in terms of 6-month progression-free survival and objective tumor response in these patients
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use yes stratum closed to accrual as of 05152003 for phase I and phase II vs no
Phase I patients with glioma or meningioma Patients in cohorts 1 and 2 receive oral imatinib mesylate STI571 once daily on days 1-28 Patients in cohorts 3-5 receive oral STI571 twice daily on days 1 and 3-28 of the first course and on days 1-28 of subsequent courses Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II patients with glioma glioblastoma multiforme patients excluded as of 05152003 Patients receive oral STI571 at the MTD determined in phase I 1-2 times daily for 4 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months Glioblastoma multiforme patients excluded from phase II as of 05132003
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 |
|---|---|---|---|
| UCLA-0101024 | Other GrantFunding Number | National Cancer Institute | None |
| CDR0000068437 | REGISTRY | None | None |
| NCI-01-C-0243 | OTHER_GRANT | None | None |