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NCT01189266 · ClinicalTrials.gov registry record · Phase 1

Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
79
Enrollment target

NCT01189266: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01189266 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01189266, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
79 participants
Enrollment target

Study Summary

This phase I/II trial studies the side effects and best dose of vorinostat and to see how well it works when given together with radiation therapy followed by maintenance therapy with vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma (a brainstem tumor). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with radiation therapy may kill more tumor cells.

Primary Outcome

The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy

Interventions

  • OTHER Laboratory Biomarker Analysis
  • RADIATION Intensity-Modulated Radiation Therapy
  • DRUG Vorinostat
  • RADIATION 3-Dimensional Conformal Radiation Therapy

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2010-08-09
Est. Completion 2021-09-30
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01189266 record still lists

NCT01189266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).

The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01189266 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01189266 about?

NCT01189266 is a clinical study titled "Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma". This phase I/II trial studies the side effects and best dose of vorinostat and to see how well it works when given together with radiation therapy followed by maintenance therapy with vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma (a brainstem tumor). V...

What is the current status of trial NCT01189266?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2010-08-09. Estimated completion is 2021-09-30.

What interventions are being tested in trial NCT01189266?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Vorinostat (DRUG), 3-Dimensional Conformal Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT01189266?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01189266's enrollment target sits among peer trials

79 696th of 2000 higher than 1,304 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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Source: ClinicalTrials.gov NCT01189266, the US trial registry maintained by the National Library of Medicine. NCT01189266 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.