A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma

NCT06668987 | Active Not Recruiting Phase 1

• 1 other identifier: 2024-08-015B
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningioma; Boron Neutron Capture Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Progression-free survival

  6 months

• Overall survival

  6 months

• Quality of life (QoL)

  6 months

Other Outcomes (1)

• The population of circulating immune cells

  6 months

Study Arms (1)

BNCT, recurrent meningioma.

EXPERIMENTAL

Single arm treated by BNCT only

Drug: B10 L-BPA Injection

Interventions

B10 L-BPA Injection DRUG

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.

BNCT, recurrent meningioma.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 20 years and older.
• Prior surgery, radiation therapy, radiosurgery, proton therapy, heavy ion therapy, or boron neutron capture therapy for the disease.
• There must be a time interval ≥ 3 months between prior radiation therapy and the scheduled BNCT.
• There must be a time interval ≥ 1 month between receipt of antitumor drugs and the scheduled BNCT.
• Measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan and ≤ 12 cm in the longest dimension.
• At least one measurable lesion that can be assessed by RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 2.
• Life expectancy ≥ 3 months in the opinion of the investigator.
• Adequate organ functions as defined below:
• Hemoglobin ≥ 8.0 g/dL. White blood cell (WBC) count ≥ 2.5 x 10\^9 /L. Neutrophil count ≥ 1.0 × 10\^9/L. Platelet count ≥ 50 × 10\^9/L. Aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN). Alanine aminotransferase (ALT) ≤ 2.5 × ULN. Serum creatinine ≤ 1.5 × ULN Estimated glomerular filtration rate(eGFR) \>=15 mL / min / 1.73m2
• Female subjects with reproductive potential must have a negative result of serum pregnancy test at the screening visit and urine pregnancy test before the B10 L-BPA administration.
• Female subject with childbearing potential as well as male subject with reproductive potential must agree to refrain from unprotected sex and use 2 methods of highly effective contraception with their partner (e.g. barrier contraceptives \[male condom, female condom, or diaphragm plus spermicide\], intrauterine device, hormonal methods \[hormone shot or injection, implants, combination oral contraceptives, or patches\]) for ≥ 6 months after the BNCT until the end of this study.
• Physically and mentally capable of participating in the study and willing to adhere to study procedures.
• Provision of signed informed consent. -

You may not qualify if:

• Patients who have an effective standard treatment option available.
• Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given.
• History of malignancy other than meningioma within 5 years (except carcinoma in situ and non-melanoma skin cancer).
• A time interval less than 3 months from previous radiation therapy for intracranial region.
• Patients who had radiation myelitits or radiation necrosis of the brain/brain stem.
• A time interval less than 3 months from last brain surgery and less than 1 month from previous chemotherapy.
• Distant metastasis outside of skull.
• Imaging studies demonstrating tumor invasion of the carotid artery.
• Carotid blowout syndrome with active bleeding within 6 months.
• The investigator will evaluate the subject's condition and determine whether to perform computed tomography angiography (CTA) to assess the health of the subject's vascular system. This evaluation will confirm whether the subject is suitable to participate in the trial.
• Note: Subjects will be eligible for the study if they have undergone stent implantation and obtained consent from the investigator.
• Active infections requiring systemic treatment.
• Patients with severe congestive heart failure or renal failure, as well as myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.
• Severe comorbidities including but not limited to poorly controlled epilepsy, poorly controlled diabetes mellitus, poorly controlled hypertension, chronic lung diseases, e.g., obstructive pneumonia, interstitial pneumonia, pulmonary fibrosis, and severe emphysema, kidney diseases, e.g., chronic renal failure, acute renal failure, phenylketonuria and nephrotic syndrome, cardiac diseases, e.g., New York Heart Association (NYHA) Functional Classification Class III or IV), phenylketonuria and/or other severe conditions in the opinion of the investigator.
• Suspected or known hypersensitivity (including allergy) to any of the drug components or contrast media.

Sponsors & Collaborators

• Heron Neutron Medical Corp.: lead

Study Sites (1)

Taipei Veterans General Hsopital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: November 1, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)