None listed
Conditions
Interventions
Drug, Medical Device, Radiation : [IP]
- Title: DMX-101
- Administration: single dose
- Route: IV
- Dose: 500mg/kg
[ID]
- DM-BNCT(Therapeutic neutron irradiation device)
- DM-BTPS(Radiation treatment
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 19 years or older and under 80 years old. 2) Histologically confirmed glioblastoma (Glioblastoma, IDH-wildtype, WHO grade 4). 3) Karnofsky Performance Status (KPS) of 60% or higher. 4) Histologically confirmed recurrence or disease progression (PD) according to RANO 2.0 criteria. 5) At least one measurable or nonmeasurable lesion* as per RANO 2.0 criteria: 6) Prior radiotherapy with a dose at or below standard radiotherapy (= 54–70 Gy/25–35 fractions). 7) An expected survival of more than 12 weeks after BNCT. 8) Confirmation of adequate hematologic, renal, and hepatic function: - ANC (granulocyte colony-stimulating factor [G-CSF] not administered within 2 weeks before testing) = 1,500/mm³. - WBC (G-CSF not administered within 2 weeks before testing) = 3,500/µL. - Platelet count (no transfusion within 1 week before testing) = 100,000/µL. - Hemoglobin (no transfusion within 1 week before testing) = 10.0 g/dL. - AST and ALT = 3 × ULN. - Serum creatinine = 1.5 × ULN. 9) Able to lie or sit in the confirmed treatment position for 30 minutes to 1 hour during BNCT simulation prescription (or set-up visit). 10) Tumor located within 7 cm from the skin surface. 11) No metallic implants such as cardiac pacemakers. 12) Voluntary consent to participate in the clinical trial by the subject (and/or a representative).
Exclusion criteria
Exclusion criteria: 1) Individuals with the following comorbidities: (1) Uncontrolled brain edema despite corticosteroid use* *: Severe uncontrolled symptoms such as headache, vomiting, dyspnea, or consciousness disturbance graded as NCI-CTCAE v5.0 grade 3 or higher. (2) Clinically significant vascular diseases (e.g., peripheral arterial thrombosis, aneurysms requiring surgery). (3) NYHA class III or higher heart disease (refer to [Appendix 3]). (4) Moderate or severe chronic obstructive pulmonary disease (COPD) according to COPD management guidelines. (5) Dyspnea classified as grade III or higher according to the ATS dyspnea scale (refer to [Appendix 4]). (6) Leptomeningeal dissemination. 2) Individuals with the following medical history: (1) Hypertensive crisis or hypertensive encephalopathy. (2) Phenylketonuria. (3) Storage dehydration or hereditary fructose intolerance. (4) Hemorrhagic diathesis or coagulopathy. (5) Clinically significant infections as judged by the investigator (e.g., sepsis, HIV). (6) Diagnosed with another malignancy† within 3 years without a disease-free state. †: Patients with basal cell carcinoma of the skin or carcinoma in situ of the cervix who received curative treatment are excluded. (7) Hypersensitivity or allergic reactions to boron or any component of the investigational product. (8) Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 24 weeks before the date of BNCT. (9) Intracranial abscess within 24 weeks before the date of BNCT. (10) Pulmonary hemorrhage or hemoptysis graded as NCI-CTCAE v5.0 grade 2 or higher within 4 weeks before the date of BNCT. 3) Individuals who have undergone the following therapies or interventions: (1) BNCT. (2) Systemic anti-angiogenic therapy (VEGF inhibitors and VEGF receptor inhibitors). (3) Radiotherapy for recurrent lesions [including interstitial brachytherapy, stereotactic radiosurgery, and re-irradiation]. (4) Radiotherapy within 24 weeks before the date of BNCT. (5) Other anti-cancer therapies (e.g., chemotherapy, immunotherapy, targeted therapy) within 4 weeks before the date of BNCT. (6) Surgery for recurrent/progressive glioblastoma‡ within 8 weeks before the date of BNCT. ‡: Minor surgeries (e.g., stereotactic biopsy) may be permitted at the investigator's discretion if the patient has fully recovered. (7) Administration or application of other investigational drugs/devices within 4 weeks before the date of BNCT. 4) (If taking corticosteroids) Individuals who did not receive a stable dose of corticosteroids or did not reduce the dosage at least one week before MRI imaging. 5) Individuals with intracranial hemorrhage detected on MRI§ §: Patients with asymptomatic hemosiderin deposition, punctate tumor-related hemorrhage, or resolved surgery-related hemorrhagic changes may be eligible. 6) Individuals unable to undergo required imaging tests (e.g., MRI, CT, PET/CT). 7) Pregnant or breastfeeding women. 8) Women and men of childbearing potential who plan to conceive or do not agree to use appropriate contraception during the clinical trial. Appropriate contraception includes: (1) Hormonal contraceptives (oral, injectable, or implantable). (2) Intrauterine device (IUD) or intrauterine system (IUS). (3) Sterilization or surgical procedures (e.g., vasectomy, hysterectomy, bilateral oophorectomy, bilateral salpingectomy). (4) Double contraception: Simultaneous use of contraceptive methods from (1)–(3) with barrier metho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-Month PFS According to RANO/RANO 2.0 Criteria | — |
Countries
Korea, Republic of
Contacts
Public ContactGi-Taek Yee
Gachon University Gil Medical Center
Outcome results
None listed