Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112736
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2005-06-02
Brief Title:
Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of OSI-774 Erlotinib and CCI-779 Temsirolimus in Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Erlotinib and temsirolimus and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth This phase III trial is studying the side effects and best dose of temsirolimus when given together with erlotinib and to see how well they work in treating patients with recurrent malignant glioma
Detailed Description:
PRIMARY OBJECTIVES
I To define the maximum tolerated dose MTD of OSI-774 erlotinib Tarceva in combination with CCI-779 temsirolimus in patients with recurrent malignant glioma who are not taking enzyme-inducing anti-epileptic drugs EIAEDs Phase I II To characterize the safety profile of OSI-774 erlotinib and CCI-779 temsirolimus Phase I III To characterize the pharmacokinetics of OSI-774 erlotinib and CCI-779 temsirolimus Phase I IV To determine the efficacy of OSI-774 erlotinib and CCI-779 temsirolimus in patients with recurrent malignant glioma as measured by 6-month progression-free survival Phase II
SECONDARY OBJECTIVES
I Overall progression-free survival Phase II II Response Phase II
TERTIARY OBJECTIVES
I To explore the association of response to treatment to the molecular phenotype of the tumor Phase II II Determine whether OSI-774 erlotinib and CCI-779 temsirolimus inhibits EGFR and mTOR and the PI3K-AKT-mTOR and RAS-ERK signaling pathways in tumor specimens taken from malignant glioma patients undergoing surgery Phase II III Tumor concentration of OSI-774 erlotinib and CCI-779 temsirolimus Phase II
OUTLINE This is a multicenter phase I dose-escalation study of temsirolimus followed by a phase II study Patients are stratified according to study phase I vs II histology at study enrollment glioblastoma multiforme or gliosarcoma vs anaplastic glioma preoperative candidacy yes vs no and presence of measurable or evaluable disease yes vs no
PHASE I Patients receive oral erlotinib once daily on days 1-28 and temsirolimus IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temsirolimus 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 receive temsirolimus at the MTD and erlotinib as in phase I
PHASE II preoperative component Patients who are surgical candidates may opt to undergo surgical resection of the tumor Beginning 5-7 days before surgery these patients receive oral erlotinib once daily until surgery Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later Beginning 2-4 weeks after surgery patients receive temsirolimus at the MTD and erlotinib as in phase I
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I portion of the study within 1-8 months A total of 50 patients 32 patients with glioblastoma multiforme and 18 with anaplastic glioma will be accrued for the phase II portion of the study within 8-12 months
I To define the maximum tolerated dose MTD of OSI-774 erlotinib Tarceva in combination with CCI-779 temsirolimus in patients with recurrent malignant glioma who are not taking enzyme-inducing anti-epileptic drugs EIAEDs Phase I II To characterize the safety profile of OSI-774 erlotinib and CCI-779 temsirolimus Phase I III To characterize the pharmacokinetics of OSI-774 erlotinib and CCI-779 temsirolimus Phase I IV To determine the efficacy of OSI-774 erlotinib and CCI-779 temsirolimus in patients with recurrent malignant glioma as measured by 6-month progression-free survival Phase II
SECONDARY OBJECTIVES
I Overall progression-free survival Phase II II Response Phase II
TERTIARY OBJECTIVES
I To explore the association of response to treatment to the molecular phenotype of the tumor Phase II II Determine whether OSI-774 erlotinib and CCI-779 temsirolimus inhibits EGFR and mTOR and the PI3K-AKT-mTOR and RAS-ERK signaling pathways in tumor specimens taken from malignant glioma patients undergoing surgery Phase II III Tumor concentration of OSI-774 erlotinib and CCI-779 temsirolimus Phase II
OUTLINE This is a multicenter phase I dose-escalation study of temsirolimus followed by a phase II study Patients are stratified according to study phase I vs II histology at study enrollment glioblastoma multiforme or gliosarcoma vs anaplastic glioma preoperative candidacy yes vs no and presence of measurable or evaluable disease yes vs no
PHASE I Patients receive oral erlotinib once daily on days 1-28 and temsirolimus IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temsirolimus 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 receive temsirolimus at the MTD and erlotinib as in phase I
PHASE II preoperative component Patients who are surgical candidates may opt to undergo surgical resection of the tumor Beginning 5-7 days before surgery these patients receive oral erlotinib once daily until surgery Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later Beginning 2-4 weeks after surgery patients receive temsirolimus at the MTD and erlotinib as in phase I
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I portion of the study within 1-8 months A total of 50 patients 32 patients with glioblastoma multiforme and 18 with anaplastic glioma will be accrued for the phase II portion of the study within 8-12 months
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 |
|---|---|---|---|
| U01CA062399 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062399 |
| NCI-2012-02921 | REGISTRY | None | None |
| CDR0000429553 | None | None | None |
| NABTC04-02 | OTHER | None | None |
| NABTC-04-02 | OTHER | None | None |