A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma (NCT06668987) | Clinical Trial Compass
CompletedPhase 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 range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and efficacy of BNCT using B10 L-BPA in treating recurrent meningioma
. 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).
. 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.