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NCT01378481 · ClinicalTrials.gov registry record · Phase 1
High-Dose Vorinostat and Fractionated Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Glioma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01378481: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01378481 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378481, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is being done to determine if an investigational cancer treatment called vorinostat combined with fractionated stereotactic radiation therapy (FSRT) is effective in treating recurrent high grade gliomas. The main goal of this research study is to determine the highest dose of vorinostat that can be given to patients with recurrent tumors. The study will also determine the potential side effects and safety of these treatment combinations. Vorinostat is a small molecule inhibitor of histone deacetylase (HDAC). HDAC inhibitors help unravel the deoxyribonucleic acid (DNA) of the cancer cells and make them more susceptible to the treatment with radiation.
Primary Outcome
Analysis of study data will be descriptive, including summary tables of toxicity. An exploratory retrospective trend analysis will be performed assessing for a correlation between plasma drug level and toxicity, using exact logistic regression models.
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Stereotactic Radiosurgery
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Vorinostat
- OTHER Pharmacological Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
Why NCT01378481 stopped before completion
NCT01378481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01378481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378481 about?
NCT01378481 is a clinical study titled "High-Dose Vorinostat and Fractionated Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Glioma". This study is being done to determine if an investigational cancer treatment called vorinostat combined with fractionated stereotactic radiation therapy (FSRT) is effective in treating recurrent high grade gliomas. The main goal of this research study is to determine the highest dose of vorinostat t...
What is the current status of trial NCT01378481?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-06. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01378481?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Stereotactic Radiosurgery (RADIATION), Therapeutic Conventional Surgery (PROCEDURE), Vorinostat (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01378481?
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 NCT01378481's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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