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Clinical Trial Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor 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 and to see how well it works in treating patients with newly diagnosed glioblastoma multiforme.


Clinical Trial Description

OBJECTIVES: Primary - To define the maximum tolerated dose of everolimus (up to an established dose of 10 mg/day) when combined with concurrent radiotherapy and temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I) - To determine the efficacy of everolimus in combination with radiotherapy and temozolomide followed by adjuvant everolimus in combination with temozolomide, as measured by progression-free survival, in these patients. (Phase II) Secondary - To characterize the safety profile of everolimus in combination with radiotherapy and temozolomide in these patients. (Phase I) - To determine the overall survival of these patients. (Phase II) - To further evaluate the safety profile of everolimus in combination with radiotherapy and temozolomide in these patients. (Phase II) - To determine if activation of the Akt/mTOR axis predicts response to everolimus. (Phase II) - To determine if there is an association between tumor MGMT gene methylation status and response to everolimus. (Phase II) OUTLINE: This is a multicenter, phase I, dose-escalation study of everolimus followed by a phase II, randomized study. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01062399
Study type Interventional
Source Radiation Therapy Oncology Group
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2010
Completion date May 20, 2022

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