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Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Trial NCT01062399

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.

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NCT01062399
Early Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT01062399
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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

Study Focus

concurrent RAD001 10 mg/day

Interventional

drug

Sponsor & Location

Radiation Therapy Oncology Group

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

Early Phase 1

Dec 01, 2010

May 20, 2022

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 system
Malignant neoplasm: Central nervous system, unspecified
Benign neoplasm of brain and other parts of central nervous system
Malignant neoplasm of brain
Secondary malignant neoplasm of other and unspecified parts of nervous system

Data Source

ClinicalTrials.gov

NCT01062399

Non-Device Trial