Protocol
12-082
Full 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 (COG ACNS0822)
Purpose
High-grade gliomas are very challenging to treat successfully. In this study, researchers are evaluating radiation therapy plus vorinostat, bevacizumab, or temozolomide followed by maintenance chemotherapy in children newly diagnosed with high-grade gliomas.
Vorinostat is approved for a rare cancer called cutaneous T-cell lymphoma, but its use in children and in patients with glioma is considered investigational. It is a drug called a histone deacetylase (HDAC) inhibitor. It prevents cancer cells from reproducing by interfering with certain signaling pathways. Bevacizumab and temozolomide are both already used to treat glioma in adults.
In this Children’s Oncology Group study, patients will be randomly assigned to treatment with radiation therapy and either vorinostat, bevacizumab, or temozolomide. All patients will then receive maintenance therapy with bevacizumab and temozolomide to try to reduce the risk of recurrence.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be aged 3 to 21 years.
- Patients must be newly diagnosed with a high-grade glioma.
- Patients may not have received any prior chemotherapy, radiotherapy, immunotherapy, or a bone marrow transplant.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
For more information and to inquire about eligibility for this study, please contact Dr. Stephen W. Gilheeney at 212-639-3973.
Disease(s)
Pediatric Brain Tumors: Brain Cancer
Locations
Related Diseases
