Phase I dose escalation study on bicalutamide, an androgen receptor antagonist, as a radiosensitizer combining with brain re-irradiation to treat recurrent/progressive glioblastoma/high grade glioma
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC), Radiation Oncology (RADONC)
Current Status: Not open
Phase: I (Cancer Control)
Principal Investigator: Zhang, Chi
Contact Information:
Michaela Savine
misavine@unmc.edu
Summary
Primary objective:
1. To evaluate the safety when combining partial brain re-irradiation with bicalutamide.
Side effects of the study drug combined with RT will be assessed per CTCAE 5.0 criteria.
Secondary objectives:
1. To estimate the rate of objective response (ORR) in subjects with treatment. Response Assessment in Neuro-Oncology (RANO) criteria will be used to estimate the ORR.
2. To estimate the 6-month progression-free survival rate.
3. To evaluate the impact of combining bicalutamide with brain re-irradiation on quality of survival, as measured by changes to scores on the Montreal Cognitive Assessment (MoCA) and Karnofsky performance status.