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NCT01062399

Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma
Radiation Therapy Oncology Group·Early Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Brain and Central Nervous System Tumors
Drug/Device/Intervention
concurrent RAD001 10 mg/day
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Radiation Therapy Oncology Group
Location
Newark,Gainesville,Jacksonville Beach,Jacksonville,Jacksonville,Jacksonville,Orange Park,Palatka,Saint Augustine,Tampa,Atlanta,Indianapolis,Baltimore,Boston,Pascagoula,Livingston,Albany,Rochester,Roch, Canada,Israel,United States of America
Timeline & enrollment
Phase
Early Phase 1
Start date
Dec 01, 2010
End date
May 20, 2022
Enrollment
279 participants
Primary outcome

Phase I: Number of Patients With Dose-limiting Toxicity (DLT),Phase II: Progression-free Survival (PFS)

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.

ICD-10 classifications
Malignant neoplasm: Overlapping lesion of brain and other parts of central nervous systemMalignant neoplasm: Central nervous system, unspecifiedBenign neoplasm of brain and other parts of central nervous systemMalignant neoplasm of brainSecondary malignant neoplasm of other and unspecified parts of nervous system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01062399
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01062399 through Pure Global AI's free database. This Early Phase 1 trial is sponsored by Radiation Therapy Oncology Group and is currently Completed. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 279 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.