Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329719
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2006-05-23
Brief Title:
Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of Sorafenib and CCI-779 in Patients With Recurrent Glioblastoma
Status:
COMPLETED
Status Verified Date:
2018-09
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:
This phase III trial studies the side effects and best dose of temsirolimus when given together with sorafenib tosylate and to see how well they work in treating patients with glioblastoma that has come back Sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as temsirolimus work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sorafenib tosylate and temsirolimus may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving sorafenib tosylate with temsirolimus may kill more tumor cells
Detailed Description:
Primary Objective -
Phase I closed to accrual as of 01112008
To establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants EIACs
Phase II closed to accrual as of 12072012
To assess the efficacy of temsirolimus and sorafenib in the treatment of recurrent glioblastoma in non-EIAC patients as measured by progression-free survival status at six months PFS6
Secondary Objectives -
Phase I closed to accrual as of 01112008
I To define the safety profile of temsirolimus and sorafenib in non-EIAC patients
II To assess the evidence of antitumor activity
Phase II closed to accrual as of 12072012
I To assess the safety and toxicities of temsirolimus and sorafenib in the above-noted patient populations
Outline This is a multicenter phase I dose-escalation study followed by a phase II study
Phase I Arm A Patients receive sorafenib orally PO twice daily BID on days 1-28 and temsirolimus intravenously IV over 30 minutes on days 1 8 15 and 22 Treatment repeats 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 are assigned to 1 of 3 treatment groups
Group 1 Arm B Patients receive sorafenib and temsirolimus as in phase I at the MTD patients not undergoing surgery
Group 2 Arm C Patients receive sorafenib PO BID on days 1-8 15 doses and temsirolimus IV at the MTD on day 1 Patients undergo surgery on day 8 patients undergoing surgery After recovering from surgery patients receive sorafenib and temsirolimus as in phase I at the MTD
Group 3 Arm D Patient receive sorafenib and temsirolimus as in phase I at the MTD patients who have received prior anti-vascular endothelial growth factor VEGF therapy and are not undergoing surgery
Biopsy or resected tissue and blood are collected prior to treatment usually at diagnosis and analyzed for biomarkers After completion of study treatment patients are followed every 6 months for 5 years and then annually thereafter
Phase I closed to accrual as of 01112008
To establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants EIACs
Phase II closed to accrual as of 12072012
To assess the efficacy of temsirolimus and sorafenib in the treatment of recurrent glioblastoma in non-EIAC patients as measured by progression-free survival status at six months PFS6
Secondary Objectives -
Phase I closed to accrual as of 01112008
I To define the safety profile of temsirolimus and sorafenib in non-EIAC patients
II To assess the evidence of antitumor activity
Phase II closed to accrual as of 12072012
I To assess the safety and toxicities of temsirolimus and sorafenib in the above-noted patient populations
Outline This is a multicenter phase I dose-escalation study followed by a phase II study
Phase I Arm A Patients receive sorafenib orally PO twice daily BID on days 1-28 and temsirolimus intravenously IV over 30 minutes on days 1 8 15 and 22 Treatment repeats 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 are assigned to 1 of 3 treatment groups
Group 1 Arm B Patients receive sorafenib and temsirolimus as in phase I at the MTD patients not undergoing surgery
Group 2 Arm C Patients receive sorafenib PO BID on days 1-8 15 doses and temsirolimus IV at the MTD on day 1 Patients undergo surgery on day 8 patients undergoing surgery After recovering from surgery patients receive sorafenib and temsirolimus as in phase I at the MTD
Group 3 Arm D Patient receive sorafenib and temsirolimus as in phase I at the MTD patients who have received prior anti-vascular endothelial growth factor VEGF therapy and are not undergoing surgery
Biopsy or resected tissue and blood are collected prior to treatment usually at diagnosis and analyzed for biomarkers After completion of study treatment patients are followed every 6 months for 5 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2009-00652 | REGISTRY | None | None |
| CDR0000472240 | None | None | None |
| NCCTG-N0572 | None | None | None |
| N0572 | OTHER | None | None |
| N0572 | OTHER | None | None |
| U10CA180821 | NIH | None | None |