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NCT00553150 · ClinicalTrials.gov registry record · Phase 1
Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
A Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT00553150: Completed Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00553150 is a Phase 1 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553150, a Phase 1 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study Summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking some of the blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer 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 in treating patients with newly diagnosed glioblastoma.
Primary Outcome
Patients were assessed during RT for dose-limiting toxicities (DLT), which were defined as failure to deliver greater than 75% of the planned doses of TMZ or RAD001 during RT, interruption of RT for more than 5 days because of toxicity, or the following: \>= Grade 3 diarrhea or skin rash; \>= Grade 4 neutropenia, leukopenia, or thrombocytopenia; \>= Grade 4 hypertriglyceridemia, hypercholesterolemia, or hyperglycemia despite optimal medial management, other \>= 3 non-hematologic events; or \>= G
Interventions
- DRUG temozolomide
- DRUG everolimus
- RADIATION radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2009-03 |
| Est. Completion | 2019-11-15 |
| Phase | Phase 1 |
What the finished NCT00553150 record still lists
NCT00553150 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 3 interventions - of which temozolomide is the first listed.
NCT00553150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00553150 about?
NCT00553150 is a clinical study titled "Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma". RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking some of the blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cell...
What is the current status of trial NCT00553150?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2009-03. Estimated completion is 2019-11-15.
What interventions are being tested in trial NCT00553150?
The interventions under investigation include: temozolomide (DRUG), everolimus (DRUG), radiation (RADIATION).
Who is sponsoring clinical trial NCT00553150?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00553150's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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