Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387400
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2006-10-12
Brief Title:
Temozolomide Everolimus in Newly Diagnosed Recurrent or Progressive Malignant Glioblastoma Multiforme
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of Temozolomide and RAD001C in Patients With Malignant Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2020-04
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 such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Giving temozolomide together with everolimus may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of everolimus when given together with temozolomide in treating patients with newly diagnosed recurrent or progressive malignant glioblastoma multiforme
PURPOSE This phase I trial is studying the side effects and best dose of everolimus when given together with temozolomide in treating patients with newly diagnosed recurrent or progressive malignant glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated doses and the recommended phase II doses of everolimus when administered with standard-dose temozolomide in patients with newly diagnosed recurrent or progressive glioblastoma multiforme
Determine the toxicity of this regimen in these patients
Secondary
Determine the efficacy of this regimen in patients with measurable disease at baseline
Identify correlates of activity by molecular study of paraffin-embedded tumor samples from these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a nonrandomized nonblinded parallel-group multicenter dose-escalation study of everolimus Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs yes vs no
Patients receive oral temozolomide once daily on days 2-5 in course 1 and on days 1-5 in all subsequent courses Patients also receive oral everolimus once daily on days 1-28 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Patients with newly diagnosed disease receive up to 6 courses of treatment Patients with recurrent disease who achieve a response partial or complete response or stable disease may continue treatment until disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of everolimus 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 during the first course of therapy Once the MTD is determined an additional 6 patients are treated at the MTD
Patients archival diagnostic tumor tissue is evaluated during study for correlative molecular studies by immunohistochemical staining of mammalian target of rapamycin inhibition status mTOR activity and pretreatment molecular markers Blood samples are taken periodically during course 1 for pharmacokinetic studies
After completion of study therapy patients are followed at 4 weeks Patients with stable or responding disease are then followed every 3 months until relapse or progression
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the maximum tolerated doses and the recommended phase II doses of everolimus when administered with standard-dose temozolomide in patients with newly diagnosed recurrent or progressive glioblastoma multiforme
Determine the toxicity of this regimen in these patients
Secondary
Determine the efficacy of this regimen in patients with measurable disease at baseline
Identify correlates of activity by molecular study of paraffin-embedded tumor samples from these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a nonrandomized nonblinded parallel-group multicenter dose-escalation study of everolimus Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs yes vs no
Patients receive oral temozolomide once daily on days 2-5 in course 1 and on days 1-5 in all subsequent courses Patients also receive oral everolimus once daily on days 1-28 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Patients with newly diagnosed disease receive up to 6 courses of treatment Patients with recurrent disease who achieve a response partial or complete response or stable disease may continue treatment until disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of everolimus 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 during the first course of therapy Once the MTD is determined an additional 6 patients are treated at the MTD
Patients archival diagnostic tumor tissue is evaluated during study for correlative molecular studies by immunohistochemical staining of mammalian target of rapamycin inhibition status mTOR activity and pretreatment molecular markers Blood samples are taken periodically during course 1 for pharmacokinetic studies
After completion of study therapy patients are followed at 4 weeks Patients with stable or responding disease are then followed every 3 months until relapse or progression
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CAN-NCIC-IND162 | REGISTRY | None | None |
| CDR0000507616 | OTHER | PDQ | None |