Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.
- 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 MRI/CT 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 MRI/CT scan will be done
every 2 cycles (8 weeks).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the efficacy of lenalidomide with conventional radiation therapy in the treatment of patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
3 years
No
Patrick Y. Wen, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
05-222
NCT00165477
September 2005
July 2009
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Virginia | Charlottesville, Virginia 22908 |