Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047073
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2002-10-03
Brief Title:
Sirolimus in Treating Patients With Glioblastoma Multiforme
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Modified Phase III Trial Of Rapamycin In Patients With Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2012-07
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 Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from dividing so they stop growing or die Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase III trial to study the effectiveness of sirolimus in treating patients who have glioblastoma multiforme that did not respond to previous radiation therapy
PURPOSE Phase III trial to study the effectiveness of sirolimus in treating patients who have glioblastoma multiforme that did not respond to previous radiation therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of sirolimus in patients with glioblastoma multiforme
Determine the safety profile of this drug in these patients
Determine the efficacy of this drug in terms of 6-month progression-free survival and objective response in these patients
OUTLINE This is a dose-escalation study
Phase I Patients receive oral sirolimus for 5-7 days before surgery Patients then undergo surgical resection Patients resume oral sirolimus once daily after full recovery from surgery Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oral sirolimus as in phase I at the dose determined in that phase
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-12 patients will be accrued for phase I of the study within 3-12 months A total of 32 patients will be accrued for phase II of the study
Determine the maximum tolerated dose of sirolimus in patients with glioblastoma multiforme
Determine the safety profile of this drug in these patients
Determine the efficacy of this drug in terms of 6-month progression-free survival and objective response in these patients
OUTLINE This is a dose-escalation study
Phase I Patients receive oral sirolimus for 5-7 days before surgery Patients then undergo surgical resection Patients resume oral sirolimus once daily after full recovery from surgery Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oral sirolimus as in phase I at the dose determined in that phase
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-12 patients will be accrued for phase I of the study within 3-12 months A total of 32 patients will be accrued for phase II of the study
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 |
|---|---|---|---|
| NCI-G02-2114 | None | None | None |
| UCLA-0203078 | None | None | None |