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Clinical Trial COGACNS0822

Title

A Randomized Phase II/III Study of Vorinostat (IND# 71976) and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab (IND# 7921) and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Children with Newly Diagnosed High-Grade Gliomas

Principal Investigator(s)

Adam Esbenshade

Details

  • Protocol No. COGACNS0822
  • Open Date: 02/13/2012
  • Staging: Phase II/III
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: 1.1.1 - To identify the dose of vorinostat that is feasible when given in combination with radiotherapy (RT) in patients with newly diagnosed high-grade gliomas (HGG). 1.1.2 - Phase II: To evaluate if either vorinostat (using MTD from feasibility phase) or bevacizumab gives a more promising outcome compared to temozolomide, as measured by one-year event-free survival (EFS), when given in combination with radiotherapy (RT) followed by maintenance chemotherapy with bevacizumab and temozolomide in patients with newly diagnosed high-grade gliomas (HGG). 1.1.3 - Phase III: To determine if the agent that has a more promising outcome than temozolomide in the Phase II portion, or the agent with the higher outcome between vorinostat and bevacizumab if both are more promising than temozolomide in the Phase II portion, results in superior event-free survival (EFS) compared to temozolomide, when given in combination with radiotherapy (RT) followed by maintenance chemotherapy with bevacizumab and temozolomide in patients with newly diagnosed high-grade gliomas (HGG).
  • Disease Sites: Neuro-Oncology; Pediatrics
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics; Radiotherapy
  • Drugs: Avastin; Bevacizumab; TMZ; Temodar; Temozolomide; Vorinostat (ZOLINZA)
  • Participating Institutions: Vanderbilt University
  • Secondary Protocol No: ACNS0822

Description

Eligibility

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