NCT06501911

A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to learn about a type of brain cancer called high-grade glioma. This study is for people who have previously received treatment for brain cancer, but the cancer has come back or gotten worse after treatment. The main question this study 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 experienced * Visit the clinic once every 8 weeks for checkups and tests

Detailed description

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.

Conditions

• Recurrent Glioblastoma
• Recurrent High-grade Glioma

Interventions

Type	Name	Description
DRUG	Bicalutamide	Participants will receive daily oral bicalutamide for six (6) months. The dose will be determined by the cohort to which the participant is enrolled as well as the toxicities experienced by previously enrolled cohorts.
RADIATION	Intensity-modulated radiation therapy (IMRT)	Participants will receive 35 Gy delivered in 10 fractions, administered once daily on weekdays.

Timeline

• Start date: 2025-04-08
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2024-07-15
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study