CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
Vorinostat +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01189266
NCT01189266Phase 2Completed

A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)

National Cancer Institute (NCI)·interventional·Posted Aug 26, 2010·Updated Oct 28, 2021

In Brief

A Phase 2 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, and 2 other interventions for Anaplastic Astrocytoma and 3 related conditions. Completed, enrolled 79 participants across 180 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2010
Enrollment StartAug 9, 2010
Primary CompletionJun 30, 2017
Study CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 15.8 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo 3D conformal radiation therapy

Intensity-Modulated Radiation Therapyradiation

Undergo intensity-modulated radiation therapy

Laboratory Biomarker Analysisother

Correlative studies

Vorinostatdrug

Given PO