A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma (NCT06668987) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma
Taiwan10 participantsStarted 2024-10-14
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Age of 20 years and older.
✓. Patients with recurrent intracranial meningioma confirmed by medical imaging, classified as WHO Grade 1 to 3 according to the World Health Organization grading system for meningioma, are eligible for inclusion.
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Safety and efficacy of BNCT using B10 L-BPA in treating recurrent meningioma