Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021229
Status:
TERMINATED
Last Update Posted:
2014-07-31
First Post:
2001-07-11
Brief Title:
Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial Of STI571 In Children With Newly Diagnosed Poor Prognosis Brainstem Gliomas And Recurrent Intracranial Malignant Gliomas
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III trial to estimate the maximum tolerated dose of imatinib mesylate in newly diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness of imatinib mesylate in treating young patients who have newly diagnosed intrinsic brain stem glioma Imatinib mesylate may interfere with the growth of tumor cells by blocking the enzymes necessary for their growth Radiation therapy uses high-energy x-rays to damage tumor cells Combining imatinib mesylate with radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of imatinib mesylate after completion of radiation in children with newly diagnosed poor prognosis brainstem gliomas Phase I strata I closed to accrual as of 52804 II Determine the maximum tolerated dose MTD of imatinib mesylate in children with recurrent high-grade intracranial glioma stratified according to the use of enzyme-inducing anticonvulsant drugs EIACDs Phase I strata IIA and IIB closed to accrual as of 81503 and 81504 respectively III Determine the safety and efficacy of this drug in patients with newly diagnosed diffuse intrinsic brainstem gliomas Phase II
SECONDARY OBJECTIVES
I Explore neuroimaging and biological correlatives of therapeutic activity of this regimen in these patients Phase I all strata closed to accrual as of 81504 II Determine the pharmacokinetics of these regimens in these patients overall and by enzyme-inducing anticonvulsant drugs EIACDs Phase I all strata closed to accrual as of 81504 III Estimate the progression-free survival PFS and overall survival OS of newly diagnosed diffuse intrinsic brainstem gliomas treated with this drug Phase I and II
OUTLINE This is a phase I dose-escalation multicenter study followed by a phase II Patients are stratified according to tumor type newly diagnosed intrinsic brainstem glioma vs recurrentrefractory intracranial high-grade glioma Patients in stratum II phase I only are further stratified according to concurrent use of enzyme-inducing anticonvulsant drugs EIACDs yes vs no Patients are assigned to one of three strata in the phase I study
Phase I
Stratum I newly diagnosed brainstem glioma Patients undergo radiotherapy once daily five days a week for 6 weeks Beginning 1-3 weeks after completion of radiotherapy patients without evidence of intratumoral bleed receive oral imatinib mesylate twice daily Imatinib mesylate treatment repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity Closed to accrual as of 52804
Stratum II A recurrent or refractory high-grade intracranial gliomasno concurrent EIACDs Patients receive imatinib mesylate as in stratum I Closed to accrual as of 81503
Stratum II B recurrent or refractory high-grade intracranial gliomas and concurrent EIACDs Patients receive imatinib mesylate as in stratum I Closed to accrual as of 81504
Cohorts of 2-3 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which it is estimated that 20 of patients will experience dose-limiting toxicity MTDs are independently estimated in each strata For stratum I newly diagnosed brain stem gliomas the dose level which at least 5 of 6 patients experience no dose-limiting toxicity will be the dose used in the efficacy and safety phase phase II
Phase II Open to accrual as of 52804
Stratum I only Patients undergo radiotherapy as in phase I Patients receive imatinib mesylate at the MTD established in phase I
Patients enrolled in the phase I portion and not treated at the MTD are to be followed for the shortest of 1 three months after the last protocol based treatment or 2 the date other therapy is initiated Stratum I patients treated at the MTD in the phase I portion and all patients in the phase II portion of the study are to be followed until death or withdrawal from the study
PROJECTED ACCRUAL Approximately 140 patients will be accrued for this study within 2 years
I Determine the maximum tolerated dose MTD of imatinib mesylate after completion of radiation in children with newly diagnosed poor prognosis brainstem gliomas Phase I strata I closed to accrual as of 52804 II Determine the maximum tolerated dose MTD of imatinib mesylate in children with recurrent high-grade intracranial glioma stratified according to the use of enzyme-inducing anticonvulsant drugs EIACDs Phase I strata IIA and IIB closed to accrual as of 81503 and 81504 respectively III Determine the safety and efficacy of this drug in patients with newly diagnosed diffuse intrinsic brainstem gliomas Phase II
SECONDARY OBJECTIVES
I Explore neuroimaging and biological correlatives of therapeutic activity of this regimen in these patients Phase I all strata closed to accrual as of 81504 II Determine the pharmacokinetics of these regimens in these patients overall and by enzyme-inducing anticonvulsant drugs EIACDs Phase I all strata closed to accrual as of 81504 III Estimate the progression-free survival PFS and overall survival OS of newly diagnosed diffuse intrinsic brainstem gliomas treated with this drug Phase I and II
OUTLINE This is a phase I dose-escalation multicenter study followed by a phase II Patients are stratified according to tumor type newly diagnosed intrinsic brainstem glioma vs recurrentrefractory intracranial high-grade glioma Patients in stratum II phase I only are further stratified according to concurrent use of enzyme-inducing anticonvulsant drugs EIACDs yes vs no Patients are assigned to one of three strata in the phase I study
Phase I
Stratum I newly diagnosed brainstem glioma Patients undergo radiotherapy once daily five days a week for 6 weeks Beginning 1-3 weeks after completion of radiotherapy patients without evidence of intratumoral bleed receive oral imatinib mesylate twice daily Imatinib mesylate treatment repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity Closed to accrual as of 52804
Stratum II A recurrent or refractory high-grade intracranial gliomasno concurrent EIACDs Patients receive imatinib mesylate as in stratum I Closed to accrual as of 81503
Stratum II B recurrent or refractory high-grade intracranial gliomas and concurrent EIACDs Patients receive imatinib mesylate as in stratum I Closed to accrual as of 81504
Cohorts of 2-3 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which it is estimated that 20 of patients will experience dose-limiting toxicity MTDs are independently estimated in each strata For stratum I newly diagnosed brain stem gliomas the dose level which at least 5 of 6 patients experience no dose-limiting toxicity will be the dose used in the efficacy and safety phase phase II
Phase II Open to accrual as of 52804
Stratum I only Patients undergo radiotherapy as in phase I Patients receive imatinib mesylate at the MTD established in phase I
Patients enrolled in the phase I portion and not treated at the MTD are to be followed for the shortest of 1 three months after the last protocol based treatment or 2 the date other therapy is initiated Stratum I patients treated at the MTD in the phase I portion and all patients in the phase II portion of the study are to be followed until death or withdrawal from the study
PROJECTED ACCRUAL Approximately 140 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000068761 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA081457 |
| PBTC-006 | OTHER | None | None |
| U01CA081457 | NIH | None | None |