A Phase 1/2 Trial for Patients with Newly Diagnosed High Grade Glioma Treated with Concurrent Radiation Therapy, Temozolomide, and BMX-001
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro
Current Status: Open to accrual
Phase: I/II
Principal Investigator: Zhang, Chi
Contact Information:
Amy Filler-Katz, RN, BSN, CCRP
402-552-2790
afillerkatz@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02655601?cond=NCT02655601&draw=2&rank=1#eligibility
Summary
This is a Phase 2 study of newly diagnosed patients with high grade glioma (HGG) undergoing standard radiation therapy and temozolomide. BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against deterioration of cognition and impairment of quality of life. Both the safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be assessed. The investigators also hypothesize that the addition of BMX-001 will positively impact the overall survival and improve objective measures of cognition in newly diagnosed high grade glioma patients. In light of the findings that BMX-001 can spare radiation-induced hair loss in a mouse model, we will evaluate and describe hair loss as an exploratory outcome in HGG patients by evaluating hair at baseline and then every 8 weeks. Another exploratory endpoint, based on pre-clinical findings that BMX-001 protects white matter from radiation-induced damage, will be white matter integrity assessed using MRI diffusion tensor imaging.