Recurrent malignant glioma after standard treatment
Conditions
Interventions
BNCT is performed in combination with a cyclotron neutron irradiation system (NeuCure) and a boron drug (Steboronin) in patients with recurrent malignant glioma after standard treatment. The drug admi
Sponsors
Nihei Keiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A histopathological diagnosis of malignant glioma has been obtained. 2.Receiving bevacizumab treatment for recurrence after standard treatment. 3. Having an evaluable lesion, which obviously recurred by MRI after bevacizumab administration. Recurrence is defined as progression disease (PD) in RANO criteria by MRI. 4. Surgical treatment is difficult. 5. The age at the time of obtaining consent is between 20 and 79 years old. 6. Written consent has been obtained from the patient or the legal representative for participation in the research. 7. Karnofsky performance status is 60 percent or higher. 8. No obvious tumor growth is observed on the contralateral cerebral hemisphere or infratentorial area by MRI (no contrast-enhanced/contrast-enhanced). 9. Expected to survive for 3 months or more, and to visit outpatient clinic 3 months after BNCT. 10. The functions of major organs are maintained, and the clinical laboratory test values meet the following conditions at the time of obtaining consent. White blood cell count >= 3,000/microL Neutrophil count >= 1,500/maicroL Hemoglobin >= 8.0 g/dL Platelet count >= 100,000/microL AST =< 100 IU/L ALT =< 100 IU/L Total bilirubin =< 1.5 mg/dL Serum creatinine =< 1.5 mg/dL Proteinuria =< +
Exclusion criteria
Exclusion criteria: Patients with the following medical conditions or circumstances are excluded. 1. Medullary cavity dissemination. 2. Infections that require intravenous administration of antibiotics, antiviral drugs, antifungal drugs, etc. 3. Serious complications (heart disease, pulmonary fibrosis / interstitial pneumonia, bleeding tendency, uncontrolled hypertension, diabetes, etc.). 4. Phenylketonuria. 5. Currently bleeding (intracranial bleeding, gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, hemoptysis, etc.). 6. Even with oral anticoagulants, poor control or PT-INR is over 2.5. 7. History of severe hypersensitivity to MRI contrast medium, ingredients of Steboronine or 18F-FBPA. 8. Pregnant women or lactating women. 9. Participating in other clinical trials. 10. In addition, the patient judged by the principal investigator or the doctor in charge to be inappropriate for conducting this research safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate is defined as CR + PR ratio for all cases, based on the maximum effect calculated from T/N (tumor SUV / contralateral normal brain SUV mean) with 18F-BPA-PET 3 months after BNCT CR: T/N is 1.0 or less PR: Decrease of T/N is 25 percent or more SD: Other than CR, PR, or PD PD: Increase of T/N is 25 percent or more | — |
Secondary
| Measure | Time frame |
|---|---|
| Best response rate using MRI images after BNCT | — |
Contacts
Public ContactMotomasa Furuse
Osaka Medical and Pharmaceutical University Hospital
Outcome results
None listed