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NCT00731731 · ClinicalTrials.gov registry record · Phase 1
Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
NCT00731731: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00731731 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 125 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00731731, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of vorinostat when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 vorinostat together with temozolomide and radiation therapy may kill more tumor cells.
Primary Outcome
The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT. \> \> DLT will be defined as any of the following events occurring during treatment with vorinostat
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temozolomide
- PROCEDURE Cognitive Assessment
- DRUG Vorinostat
- RADIATION 3-Dimensional Conformal Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2009-07-10 |
| Est. Completion | 2019-11-01 |
| Phase | Phase 1 |
What the finished NCT00731731 record still lists
NCT00731731 is an interventional study that assigns participants to a tested intervention. The registered 125 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 (108% higher).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00731731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00731731 about?
NCT00731731 is a clinical study titled "Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme". This phase I/II trial studies the side effects and best dose of vorinostat when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme. Vorinostat may stop the growth of tumor cells by blocking some of th...
What is the current status of trial NCT00731731?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2009-07-10. Estimated completion is 2019-11-01.
What interventions are being tested in trial NCT00731731?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Cognitive Assessment (PROCEDURE), Vorinostat (DRUG), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT00731731?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00731731's enrollment target sits among peer trials
125 467th of 2000 higher than 1,530 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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