Ignite Creation Date:
2024-05-05 @ 9:25 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00883298
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2009-04-16
Brief Title:
Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
Sponsor:
Center for Neurosciences Tucson
Organization:
Center for Neurosciences Tucson
Study Overview
Official Title:
Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Primary objective - to determine the 6-month progression free survival PFS of adult patients with recurrent glioblastoma multiformegliosarcoma treated with bi-weekly temozolomide plus Avastin bevacizumab
Secondary objectives - to determine radiographic response including specialized MRI sequences safety and overall survival of adult patients with with recurrent glioblastoma multiformegliosarcoma treated with bi-weekly temozolomide plus bevacizumab Avastin Additionally tumor DNA MGMT analysis as it relates to survival will be evaluated
Secondary objectives - to determine radiographic response including specialized MRI sequences safety and overall survival of adult patients with with recurrent glioblastoma multiformegliosarcoma treated with bi-weekly temozolomide plus bevacizumab Avastin Additionally tumor DNA MGMT analysis as it relates to survival will be evaluated
Detailed Description:
This is a phase II study of the combination of Avastin and temozolomide for patients with recurrent glioblastoma multiforme Avastin is administered intravenously at a dose of 10 mgkg on days 1 and 15 every 28 days and temozolomide is administered at a dose of 100 mgm2 on days 1-5 and 15-19 every 28 days one cycle Patients will have a baseline MRI an MRI scan after the first cycle and every other cycle after that If there is no evidence of disease progression or unacceptable toxicity patients will receive one year of therapy If there is evidence of added benefit eg tumor regression patients can stay on treatment longer than one year per investigator discretion
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