Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking some of the blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with temozolomide and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma.
Brain and Central Nervous System Tumors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Evaluation of Everolimus (RAD001), Radiation and Temozolomide (TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma|
- Maximum Tolerated Dose (MTD) of everolimus (RAD001) in combination with temozolomide (TMZ) and 3D-conformal radiotherapy (RT) or intensity-modulated radiotherapy (IMRT) followed by adjuvant TMZ with or without RAD001 (Phase I) [ Time Frame: Up to 49 days ] [ Designated as safety issue: Yes ]
- Survival at 52 weeks (Phase II) [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
- Response rate (Phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Time to progression (Phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Progression-free-survival at 6 months (Phase II) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Everolimus (RAD001), Radiation (RT), Temozolomide (TMZ)
Patients receive oral everolimus and oral temozolomide and 3D-conformal radiotherapy or IMRT as in phase I. Patients will undergo a 4-6 week rest period in course 2 and then proceed to adjuvant therapy.
Adjuvant therapy with everolimus and temozolomide (courses 3-8): Patients receive oral everolimus and oral temozolomide as in phase I.
Adjuvant therapy with everolimus alone (courses 9 and all subsequent courses): Patients receive oral everolimus as in phase I.
All patients undergo fludeoxyglucose (FDG)- or fluorothymidine-labeled PET/CT scans at baseline and periodically during treatment.
|Drug: everolimus Drug: temozolomide Radiation: radiation|
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00553150
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|Study Chair:||Jann N. Sarkaria, MD||Mayo Clinic|