Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165477
Status:
COMPLETED
Last Update Posted:
2010-03-10
First Post:
2005-09-09
Brief Title:
Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2010-03
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:
- The purpose of this study is to find out if the combination of lenalidomide and radiation therapy is effective in controlling tumor growth in patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma
Detailed Description:
Patients will receive lenalidomide orally once daily for 21 days followed by a one week rest period this is equivalent to one cycle
Four to seven days from the first dose of lenalidomide the patient will start radiation therapy for approximately 6-7 weeks
A neurologic exam and routine blood tests will be performed weekly while the patient is receiving radiation therapy
Following the 11th week of treatment a MRICT scan will be performed to assess the status of the tumor If there is no change or there is shrinkage in the size of the tumor the treatment will continue for another 4 week cycle
The four week cycle will continue as long as the disease remains stable or improved and the patient does not develop intolerable side effects A MRICT scan will be done every 2 cycles 8 weeks
Four to seven days from the first dose of lenalidomide the patient will start radiation therapy for approximately 6-7 weeks
A neurologic exam and routine blood tests will be performed weekly while the patient is receiving radiation therapy
Following the 11th week of treatment a MRICT scan will be performed to assess the status of the tumor If there is no change or there is shrinkage in the size of the tumor the treatment will continue for another 4 week cycle
The four week cycle will continue as long as the disease remains stable or improved and the patient does not develop intolerable side effects A MRICT scan will be done every 2 cycles 8 weeks
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