RecruitingPhase 1Phase 2NCT07003139

A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors

A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.


Sponsor

China Medical University Hospital

Enrollment

10 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase I/II study, titled 'A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.', aims to assess the efficacy of B10 L-BPA with BNCT in patients with malignant brain tumors. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for malignant brain tumors treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing boron neutron capture therapy (BNCT) — a specialized type of radiation treatment that uses a boron compound and neutron beams to selectively destroy cancer cells — for people with malignant brain tumors (grade 3 or 4) that have already been treated before. **You may be eligible if...** - You are 18 or older with a confirmed grade 3 or 4 malignant brain tumor (excluding certain specific subtypes) - You have a measurable tumor on MRI/CT and at least one lesion that can be tracked per standard criteria - It has been at least 3 months since your last radiation therapy and at least 1 month since chemotherapy - Your tumor volume is small enough (under 250 cm³, longest dimension under 7 cm) - Your general health and organ function meet the study requirements **You may NOT be eligible if...** - You have a primary CNS lymphoma, medulloblastoma, or grade 3 ependymoma - Your tumor is too large for safe treatment - Your overall health or organ function is too poor for the treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGB10 L-BPA Injection

The investigational product is B10 L-BPA Injection, is a boron-containing compound in which 10B replaces a position on L-phenylalanine at the para position with dihydroxyboron.


Locations(2)

China Medical University Hsinchu Hospital

Hsinchu, Taiwan

China Medical University Hospital

Taichung, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07003139


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