Finding studies
Finding studies
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Lead
University of Nebraska
Participants will be enrolled according to a standard cohort 3+3 dose-escalation/de-escalation study design at a starting dose of 150 mg of bicalutamide. Up to six (6) subjects will be enrolled to a given dose level until the Maximum Tolerated Dose (MTD) is reached, or until a maximum dose of 600 mg is reached. The MTD is defined as the dose below which two (2) or more of six (6) subjects experience a dose limiting toxicity (DLT). If the starting dose exceeds the MTD, the dose will be decreased until a minimum dose of 25 mg is reached. Primary Objective: 1\. To evaluate the safety when combining partial brain re-irradiation with bicalutamide. Side effects of the study drug combined with radiation therapy (RT) will be assessed per CTCAE 5.0. Secondary Objectives: 1. To estimate the rate of objective response rate (ORR) in subjects with treatment. Response Assessment in Neuro-Oncology (RANO) criteria will be used to estimate 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.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
