HGG-1MF: A Study of Bevacizumab Therapy in Patients with Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas
What is the purpose of this study?
- To determine the toxicities and feasibility of the proposed treatment regimen in patients with high-grade glioma and diffuse intrinsic brainstem glioma
- To determine the one year EFS, median PFS and median OS in newly diagnosed patients with high-grade glioma treated with radiotherapy and concurrent temozolomide, bevacizumab followed by bevacizumab, irinotecan and temozolomide for 12 courses.
- To determine the one year EFS, median PFS and median OS in newly diagnosed patients with diffuse intrinsic brainstem glioma treated with radiotherapy and concurrent bevacizumab followed by bevacizumab and irinotecan for 12 courses.
- To estimate blood levels of VEGF in circulating endothelial cells in patients at different time points
- To document changes in MR perfusion and diffusion within 24-48 hours after the 2nd dose of bevacizumab during radiotherapy.
- To correlate functional changes in tumor with responses to treatment using MR diffusion/perfusion imaging.
- To correlate the results of the biology studies in serum or tumor with PFS.
- To conduct gene expression profiling, CGH and SNP arrays in patients with high-grade gliomas.
- To assess telomerase activity, hTert expression, and telomere length in patients with HGG.
- To assess the health related quality of life of patients by parent report and, when possible, patient report at key points in therapy.
- To assess functional abilities and level of independence of patients during and following treatment.
Who can participate?
- Performance Level: Karnofsky ≥50% for patients > 10 years of age and Lansky ≥50 for patients ≤10 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Cancer - Brain and Spinal Tumors
Who should I contact for more information?
Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Where can I find additional information?