Radiosurgery and Avastin for Recurrent Malignant Gliomas
In this pilot study, 15 human subjects with recurrent, unifocal malignant gliomas up to 5-cm
in maximum dimension no longer responding to conventional chemotherapy but able to tolerate
further chemotherapy will be enrolled. The primary endpoint of this study will be the
proportion of patients who experience CNS toxicity, with secondary endpoints
progression-free survival, overall survival, steroid dosage, development of radionecrosis,
quality of life, objective radiographic response and performance status.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Central Nervous System (CNS) Toxicity
Grade 3 or higher adverse event in the "Nervous System Disorder" domain of CTCAE v4.0. CNS hemorrhage is the primary toxicity to assess.
John Kirkpatrick, MD, PhD
United States: Institutional Review Board
|Duke University Medical Center, Radiation Oncology||Durham, North Carolina 27710|