NCT00165477

Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme

Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Glioblastoma
• Gliosarcoma
• Malignant Gliomas

Interventions

Type	Name	Description
DRUG	lenalidomide	Given orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects
RADIATION	Radiation	Starting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-11-01
• Completion: 2009-07-01
• First posted: 2005-09-14
• Last updated: 2010-03-10

Locations

4 sites across 1 country: United States