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Clinical Trial 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.


Clinical Trial 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 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). ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00165477
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date July 2009

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