Phase I clinical BNCT Trial to evaluate the safty of iBNCT001 and SPM-011, Accelerator-Based novel High-Power Neutron Source in patient with newly diagnosed glioblastoma

JRCT ID: jRCT2032230554

Registered date:10/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Newly-diagnosed glioblastoma
• Date of first enrollment: 07/12/2023
• Target sample size: 18
• Study type: Interventional

Intervention(s)

- Intravenous administration of investigational drug
- Neutron irradiation of the clinical target volume with the investigational device

Outcome(s)

• Primary Outcome: Occurrence rate of dose-limiting toxicity

Secondary Outcome

Safety endpoints
- Safety and tolerability after BNCT
- Measurements of clinical laboratory tests
- Measurements of physical examination and other investigations

Efficacy endpoints
- Overall survival
- Progression-free survival
- Local control at 90 days after BNCT
- KPS measurements and change from baseline
- Neurological examination measurements and change from baseline
- Tumor responce evaluation
- Duration of response

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

- Karnofsky Performance Status is greater than 50.
- Histologically diagnosed glioblastoma (IDH-wild glioblastoma WHO grade 4 according to WHO 2016 classification) (immunostaining negative for IDH-1)
- Measurable target lesions by RANO criteria with the deepest contrast-enhanced lesion within 6 cm of the skin surface on postoperative contrast-enhanced MRI scan.

Exclude criteria

- Multiple lesions, bilateral lesions, disseminated lesions on MRI images
- Significant postoperative symptoms of increased intracranial presure
- Patients with severe systemic diseases
- Patients who have a hitory of radiotherapy to the brain
- Patients who meet the following criteria on clinical examination
a) White blood cell count less than 3,500/mm3
b) Platelet count less than 7,5000/mm3
c) AST and ALT greater than 2.5 times the upper limit of the institutional standard
d) Total bilirubin 1.5 times or more than the upper limit of the facility standard
e) BUN 2.5 times or more than the upper limit of the facility standard
f) Creatinine 1.5 times or more than the upper limit of the facility standard
- Patients for whom contrast-enhanced MRI cannot be performed
- Patients who cannot administrate temozolomide
- Patients with ongoing convulsive seizures
- Patients with active multiple cancers other than the target disease
- Patients receiving or scheduled to receive bevacizumab
- Pregnant women or patients who are unable to use contraception during the study period
- Patients with phenylketonuria

Related Information

• Primary Sponsor: Sakurai Hideyuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development