A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma
NCT Number: NCT06501911
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Recurrent Glioblastoma|Recurrent High-grade Glioma
Interventions: DRUG: Bicalutamide|RADIATION: Intensity-modulated radiation therapy (IMRT)
Sponsor: University of Nebraska
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-01

Summary:
The goal of this clinical trial is to learn about a type of brain cancer called high-grade glioma. This clinical trial is for people who have previously received treatment for their brain cancer, but their cancer has come back or gotten worse after treatment. The main question this trial aims to answer is:

- Is it safe for participants to take bicalutamide while receiving brain radiation treatment?

Participants will:

* Take bicalutamide every day for 6 months
* Receive radiation treatment to the brain
* Keep a diary of the when they take the bicalutamide and any side effects they may be experiencing
* Visit the clinic once every 8 weeks for checkups and tests

Primary Outcome Measures: The incidence of adverse events (AEs) in participants receiving study treatment (combining partial brain re-irradiation with bicalutamide), The incidence of adverse events (AEs) will be described for each dose level cohort as well as the two highest dose levels combined. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded on a scale ranging from 1 to 5, with higher numbers indicating a higher severity grade., Up to 26 months|The incidence of serious adverse events (SAEs) in participants receiving study treatment (combining partial brain re-irradiation with bicalutamide), The incidence of serious adverse events (SAEs) will be described for each dose level cohort as well as the two highest dose levels combined. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded on a scale ranging from 1 to 5, with higher numbers indicating a higher severity grade., Up to 26 months
Secondary Outcome Measures: Rate of objective response (ORR) in participants receiving treatment, The rate of objective response (ORR) in subjects receiving treatment will be assessed using Response Assessment in Neuro-Oncology (RANO) Criteria. MRI and clinical features are used to classify response as one of four categories that range from complete response to disease progression., Up to 44 months|Six-month Progression-free Survival Rate, Progression-free survival (PFS) will be estimated using the Kaplan-Meier method which estimates event probability occurring at a specific time point among subject who have not already experienced that event. PFS is defined as the time from the date of consent to disease progression or death., Up to 26 months|The impact of study treatment on quality of survival (Montreal Cognitive Assessment), To evaluate the impact of combining bicalutamide with brain re-irradiation on the quality of survival, score changes on the Montreal Cognitive Assessment (MoCA) will be measured at protocol-specified time points throughout the study. Maximum score on the assessment is 30 (scores of 30 to 26 indicate no impairment, 25 to 18 mild cognitive impairment, 17 to 10 moderate cognitive impairment, less than 10 severe cognitive impairment., Up to 44 months|The impact of study treatment on quality of survival (Karnofsky Performance Scale), To evaluate the impact of combining bicalutamide with brain re-irradiation on the quality of survival, scores changes on the Karnofsky Performance Scale will be measured. This scale ranges from 0 to 100: 100 indicates normal health and survival decreases with decreasing scores., Up to 44 months