Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recur… (NCT05737212) | Clinical Trial Compass
TerminatedPhase 1/2
Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas
Stopped: The Phase 1 clinical trial was completed, and the study was stopped to initiate a Phase 2 trial with a revised protocol.
South Korea7 participantsStarted 2022-12-05
Plain-language summary
This is a multi-centered, radiation dose escalation, open, exploratory, Phase 1/2a clinical trial on the safety, efficacy and pharmacokinetic characteristics of BNCT in patients with recurrent high-grade gliomas.
The Phase I clinical study is to explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas and characterize the safety, efficacy and pharmacokinetics.
To evaluate the primary objective of tolerability, subject population with history of exposure to a similar treatment recurrent high-grade glioma who received prior standard radiotherapy will be recruited.
The Phase IIa is to confirm the efficacy and safety after irradiation of radiation dose confirmed in the Phase I clinical study. To evaluate the primary objective of efficacy, subject population with glioblastoma (The 2021 WHO Classification of Tumors of the Central Nervous System, Glioblastoma IDH-wild type, WHO Grade 4) will be recruited.
Who can participate
Age range
19 Years – 80 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
. An adult at the age 19 or above to under 80 at the time of written consent
. Individual diagnosed with the following according to the WHO classification (2021)
. Individual who received radiation therapy at the standard level (54 to 66 Gy/25 to 35 fractions) or lower
. Individual confirmed to have disease progression\* according to the RANO criteria within 4 weeks from the screening visit (\*) At least one lesion with contrast enhancement needs to exist on the contrast enhancement MRI. For a subject who shows no lesion with contrast enhancement, functional imaging such as 18F-FET or 18F-FDOPA PET/CT needs to confirm the existence of at least one clear recurrent lesion.
. Individual who is able to lie or sit for 30 minutes to 1 hour using the fixing device of the treatment couch
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
Phase I: To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose of BNCT
Timeframe: During 90 days post-BNCT
2
Phase IIa: Proportion of 6-month PFS evaluated by central imaging according to the modified RANO criteria
. Individual with no metal implant such as a pacemaker
. Individual with KPS (Karnofsky performance score) ≥ 60
. Individual with an appropriate kidney function, lung function and bone marrow function based on the laboratory test at the screening visit
Exclusion criteria
. Individual to which a traditional therapy such as reoperation or reirradiation is effectively applicable based on consultation with a brain tumor multidisciplinary committee or consultation among two or more medical departments, including neurosurgery and radiation oncology
. Individual who received cytotoxic anticancer therapy within 4 weeks from the screening visit (including previous interstitial anticancer therapy, local medication, and convection-enhanced delivery)
. Individual who received targeted anticancer therapy (e.g., bevacizumab) within 6 weeks from the screening visit
. Individual who received radiotherapy within 6 months from the screening visit
. Individual who received a radical surgery for high-grade glioma within 4 weeks from the screening visit
. Individual who received biopsy within 1 week from the screening visit
. Individual confirmed to have a history of the following:
. Individual with uncontrollable brain edema\* even with the use of corticosteroid (\*) Uncontrollable brain edema: Uncontrolled serious headache, vomiting, dyspnea, consciousness disturbance of NCI CTCAE (Ver. 5.0) grade 3 or above. However, for a patient taking corticosteroid, the patient must at least be on a stable dose or dose reduction for 7 days prior to the MRI scan at the screening visit.