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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • RADIATION Stereotactic Radiosurgery
  • PROCEDURE Therapeutic Conventional Surgery
  • DRUG Vorinostat
  • OTHER Pharmacological Study

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-06
Est. Completion 2013-08
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01378481

The ClinicalTrials.gov registry entry for NCT01378481 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01378481 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.