Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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Official title
Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01062399
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 279 participants
Conditions and interventions
Conditions
Interventions
- concurrent RAD001 10 mg/day Drug
- concurrent temozolomide Drug
- Radiation therapy Radiation
- concurrent RAD001 2.5 mg/day Drug
- concurrent RAD001 5 mg/day Drug
- post-radiation RAD001 10 mg/day Drug
- post-radiation temozolomide Drug
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2010 (Type not available)
- Primary completion
- Jun 2016 (Actual)
- Completion
- May 20, 2022 (Actual)
- Last update posted
- Jun 9, 2022
2010 – 2022
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | — |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | — |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | — |
| Integrated Community Oncology Network at Southside Cancer Center | Jacksonville | Florida | 32207 | — |
| Baptist Medical Center South | Jacksonville | Florida | 32258 | — |
| Integrated Community Oncology Network | Jacksonville Beach | Florida | 32250 | — |
| Integrated Community Oncology Network - Orange Park | Orange Park | Florida | 32073 | — |
| Florida Cancer Center - Palatka | Palatka | Florida | 32177 | — |
| Flagler Cancer Center | Saint Augustine | Florida | 32086 | — |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| St. Vincent Oncology Center | Indianapolis | Indiana | 46260 | — |
| St. Agnes Hospital Cancer Center | Baltimore | Maryland | 21229 | — |
| Dana-Farber/Brigham and Women's Cancer Center Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | — |
| St. Barnabas Medical Center Cancer Center | Livingston | New Jersey | 07039 | — |
| New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany | New York | 12206 | — |
| University Radiation Oncology at Parkridge Hospital | Rochester | New York | 14626 | — |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | — |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | — |
| Barberton Citizens Hospital | Barberton | Ohio | 44203 | — |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | — |
| Willamette Valley Cancer Center - Eugene | Eugene | Oregon | 97401 | — |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | — |
| Cherry Tree Cancer Center | Hanover | Pennsylvania | 17331 | — |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | — |
| York Cancer Center at Apple Hill Medical Center | York | Pennsylvania | 17405 | — |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | — |
| Tyler Cancer Center | Tyler | Texas | 75702 | — |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | — |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | — |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | 53188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01062399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 9, 2022 · Synced Nov 12, 2026
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