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New treatment option for Malignant Brain Tumors
Official title A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors
ClinicalTrials.gov ID: NCT07003139
What this study is testing
What is B10 L-BPA Injection?
B10 L-BPA Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malignant brain tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age of 18 years and older.
- Patients with malignant brain tumors confirmed by histological and/or medical imaging, classified as WHO Grade 3 or 4 according to the World Health...
- 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.
- Within 4 weeks prior to the screening visit, measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan showing a...
You likely can't join if
- Patients with malignant brain tumors complicated by any of the following conditions:
- Extracranial metastases.
- Multiple intracranial lesions on both sides.
- The investigator assesses that the subject has concurrent infections or other malignant tumors and is not suitable to participate in the trial.
- Patients with malignant brain tumors are considered eligible for standard surgical treatment that is effective against the tumor.
- A time interval less than 3 months from previous radiation therapy for intracranial region.
See the full eligibility criteria
Who can join
- Age of 18 years and older.
- Patients with malignant brain tumors confirmed by histological and/or medical imaging, classified as WHO Grade 3 or 4 according to the World Health Organization of tumors of the central nervous system (CNS)...
- 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.
- Within 4 weeks prior to the screening visit, measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan showing a volume ≦ 250 cm\^3, longest dimension \< 7 cm.
- 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\^3/μL.
- Neutrophil count ≥ 1.5 × 10\^3/μL.
- Platelet count ≥ 80 × 10\^3/μL.
- 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 / 1.73m\^2
- Female people 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. However, if the subject has been...
- 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...
- Physically and mentally capable of participating in the study and willing to adhere to study procedures.
- Provision of signed informed consent.
What rules you out
- Patients with malignant brain tumors complicated by any of the following conditions:
- Extracranial metastases.
- Multiple intracranial lesions on both sides.
- The investigator assesses that the subject has concurrent infections or other malignant tumors and is not suitable to participate in the trial.
- Patients with malignant brain tumors are considered eligible for standard surgical treatment that is effective against the tumor.
- A time interval less than 3 months from previous radiation therapy for intracranial region.
- A time interval less than 3 months from last brain surgery (excluding drainage procedures and biopsy) and less than 1 month from previous chemotherapy.
- The adverse event of previous anti-tumor therapy were NCI-CTCAE V5.0 grade evaluation ≧ Class 3 (excluding alopecia and peripheral neuropathy).
- Received or expect to receive any investigational drug, biologic or device within 1 month prior to the scheduled BNCT.
- Patients receiving or expected to receive vascular endothelial growth factor inhibitors (except bevacizumab) or live attenuated vaccines within 1 month prior to the scheduled BNCT.
- Patients received major surgery within 1 month prior to the scheduled BNCT or are still recovering from a previous surgery. The investigator will evaluate the subject's condition when the subject receives major surgery...
- Patients who had radiation myelitits or radiation necrosis of the brain/brain stem.
- Patient who is prone to vascular rupture during the trial as assessed by the investigator. The Patient will be eligible for the study if they have undergone stent implantation and obtained consent from the investigator.
- 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...
- Suspected or known hypersensitivity (including allergy) to boron or any component of the study drug or contrast media.
- Subject with hereditary fructose intolerance.
- With a cardiac pacemaker or will interfere with MRI-based or CT-based dose-planning or tumor response evaluation.
- Restless people who are unable to lie or sit in a cast for more than 30 minutes.
- Any medical or psychiatric conditions that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of adverse events (AEs).
- Female subject who is planning to be pregnant or lactating during the study period.
- Subject who is considered unfit to participate in the clinical study as assessed by the investigator.
- Subject who has received prior BNCT.
The study team makes the final eligibility decision.
Where it's taking place
- Hsinchu, Taiwan
- Taichung, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hsinchu, Taiwan; Taichung, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.