Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas

Exclusion Criteria

• •1. 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
• •2. Individual who received cytotoxic anticancer therapy within 4 weeks from the screening visit (including previous interstitial anticancer therapy, local medication, and convection-enhanced delivery)
• •3. Individual who received targeted anticancer therapy (e.g., bevacizumab) within 6 weeks from the screening visit
• •4. Individual who received radiotherapy within 6 months from the screening visit
• •5. Individual who received a radical surgery for high-grade glioma within 4 weeks from the screening visit
• •6. Individual who received biopsy within 1 week from the screening visit
• •7. Individual confirmed to have a history of the following:
• •* Interstitial brachytherapy
• •* Stereotactic radiosurgery
• •* Reirradiation for a recurrent lesion
• •* Cancer immunotherapy
• •8. 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.
• •9. Individual confirmed with meningeal dissemination
• •10. Individual diagnosed with cancer in another site\* in the past at the time of the screening visit and whose disease-free period is less than 3 years (\*) Patients with the skin basal cell carcinoma and carcinoma in situ of uterine cervix who received radical treatment are excluded
• •11. Individual with hypotonic dehydration or hereditary fructose intolerance
• •12. Individual with current or a history of phenylketonuria
• •13. Individual with serious infection (e.g., sepsis, HIV) in the opinion of the investigator
• •14. Individual who has dysfunction as below or, in the investigator's opinion, who is confirmed to have clinically significant disease (e.g., unstable angina, myocardial infarction) within 6 months from the screening visit:
• •* Heart disease of Class II or above according to the New York Heart Association Functional Classification
• •* Chronic obstructive pulmonary disease of moderate or higher severity according to the Chronic obstructive pulmonary disease clinical practice, or Dyspnea of Grade II or above according to the American thoracic society dyspnea scale
• •* Hepatic dysfunction of Child-Pugh Classification B or C
• •15. Individual with current or a history of hypersensitivity to boron or any component of the study drug
• •16. Individual who received or applied other investigational product or device within 4 weeks from the screening visit
• •17. Individual who has received prior BNCT
• •18. Pregnant woman, breastfeeding woman, or individual who plans pregnancy or who does not agree to using and does not perform a medically reliable contraceptive method during the study period
• •* Women of childbearing potential\*: Use of 'intrauterine device', 'tubal surgery or tubal ligation', 'chemical barrier method (spermicide) + physical barrier method' or 'subcutaneously implanted contraceptive device + physical barrier method' (\*) Woman of any potential of pregnancy, except for those who are before their first period, who received surgical sterilization (hysterectomy or bilateral ovariectomy) or who reached menopause (absence of menstrual periods for 12 months without any specific reason)
• •* Male: Vasectomy or use of 'male condom + use of a medically reliable contraceptive method by the partner'