This Phase I/II study, titled 'A Study to Evaluate the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as a Boron Carrier in Recurrent Meningioma', aims to assess the efficacy of B10 L-BPA with BNCT in patients with recurrent meningioma. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for recurrent meningioma treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Taipei Veterans General Hsopital
Taipei, Taiwan
Safety and efficacy of BNCT using B10 L-BPA in treating recurrent meningioma
Safety will be assessed by monitoring the frequency and severity of treatment-emergent adverse events (TEAEs), including serious adverse events and those causing permanent discontinuation of therapy as per protocol. Additionally, safety evaluations will track changes in laboratory test results, vital signs, physical examination findings, and the Eastern Cooperative Oncology Group (ECOG) performance status. Efficacy of BNCT with B10 L-BPA for treating recurrent meningioma will be assessed by the percentage of subjects achieving complete response (CR) and partial response (PR). Tumor response and progression will be evaluated according to RECIST 1.1 criteria, using high-resolution CT or MRI, which defines four response categories: CR, PR, stable disease (SD), and progressive disease (PD). In addition, local control will be evaluated as a separate endpoint.
Time frame: 6 months
Progression-free survival
PFS is defined as the time from receiving the B10 L-BPA-based BNCT until progressive disease (PD) or death from any cause, whenever comes the first.
Time frame: 6 months
Overall survival
Overall survival is defined as the time from receiving the B10 L-BPA-based BNCT until death from any cause.
Time frame: 6 months
Quality of life (QoL)
The EORTC QLQ-C30 questionnaire assesses quality of life through functional, symptom, and global health scales, primarily using a 4-point scale (1='Not at All' to 4='Very Much') and a 7-point scale for two items, where higher scores indicate more symptoms. The QLQ-BN20, specifically designed for brain cancer patients, evaluates symptoms and limitations related to motor and communication issues, with higher scores reflecting greater severity. Together, these tools provide a comprehensive assessment of quality of life for brain cancer patients. To determine whether patients' quality of life improves after BNCT with B10 L-BPA, questionnaires will be administered before treatment and at 1, 3, and 6 months post-irradiation. A decrease in QLQ-C30 and QLQ-BN20 scores after irradiation will indicate improved quality of life, and the score of participants showing this improvement will be used to evaluate the benefits of BNCT with B10 L-BPA.
Time frame: 6 months
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