Clinical trialNCT01062399CompletedPhase 1/PHASE2Interventional

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

SponsorRadiation Therapy Oncology GroupEnrollment279Brain and Central Nervous System Tumors

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Prakash Chinnaiyan, MD
William Beaumont Hospital and Oakland University School of Medicine
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

36 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada

Israel

Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel

United States

Ccop - Christiana Care Health Services
Newark, Delaware, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Baptist Medical Center South
Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States
Florida Cancer Center - Palatka
Palatka, Florida, United States
Flagler Cancer Center
Saint Augustine, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
St. Vincent Oncology Center
Indianapolis, Indiana, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Dana-Farber/brigham and Women'S Cancer Center
Boston, Massachusetts, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States
New York Oncology Hematology, Pc at Albany Regional Cancer Care
Albany, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
University Radiation Oncology at Parkridge Hospital
Rochester, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
Mcglinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Concurrent RAD001 10 mg/dayConcurrent RAD001 2.5 mg/dayConcurrent RAD001 5 mg/dayConcurrent temozolomide →Post-radiation RAD001 10 mg/dayPost-radiation temozolomide

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 2010
Primary completion: 30 Jun 2016
Completion: 20 May 2022
Last update posted: 9 Jun 2022
Registered enrollment: 279
Registry id: NCT01062399

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.