A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma
NCT06501911 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2025-07-22
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
Conditions
- Recurrent Glioblastoma
- Recurrent High-grade Glioma
Interventions
- 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.
Sponsors & Collaborators
-
University of Nebraska
lead OTHER
Principal Investigators
-
Chi Zhang, MD · University of Nebraska
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-08
- Primary Completion
- 2025-07-17
- Completion
- 2025-07-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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