Glioblastoma Clinical Trial
Official title:
Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.
- 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.
- 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).
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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