Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501911
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-05
Brief Title:
A Study of Bicalutamide With Brain Re-irradiation to Treat RecurrentProgressive High Grade Glioma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Phase I Dose Escalation Study on Bicalutamide an Androgen Receptor Antagonist as a Radiosensitizer Combining With Brain Re-irradiation to Treat RecurrentProgressive GlioblastomaHigh Grade Glioma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
- 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
Detailed Description:
Patients will be enrolled according to a standard cohort 33 dose-escalationde-escalation clinical trial 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 RT will be assessed per CTCAE 50
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 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
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 50
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None