CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
Bevacizumab +2 morebiological
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/NCT01236560
NCT01236560Phase 3Completed

A Randomized Phase II/III Study of Vorinostat and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Children With Newly Diagnosed High-Grade Gliomas

National Cancer Institute (NCI)·interventional·Posted Nov 8, 2010·Updated Feb 20, 2024

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Temozolomide, and 1 other intervention for Brain Stem Glioma and 4 related conditions. Completed, enrolled 101 participants across 132 sites in 2 countries.

Detailed Summary

This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is more effective then temozolomide or bevacizumab when given together with radiation therapy in treating glioma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2010
Enrollment StartJan 26, 2011
Primary CompletionJun 30, 2023
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 15.7 years ago

Interventions

Bevacizumabbiological

Given IV

Temozolomidedrug

Given PO

Vorinostatdrug

Given PO