Recurrent malignant glioma
Conditions
Interventions
Protocol treatments consist of BNCT, additional and chemotherapy with bevacizumab. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional bevacizumab is gi
Sponsors
Osaka Medical College
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are histopathologically diagnosed with glioma 2. Patients who have relapsed after standard treatment (including BV) 3. Patients with recurrent gliomas that have a poor prognosis that falls under any of the following - It is not GBM in the initial histopathological examination, KPS at recurrence is 60% to 70% (RPA class 3)] - It is GBM in the initial histopathological examination, the age at recurrence was over 50 years old and used steroid (RPA class 7) - It is GBM in the initial histopathological examination, the age at recurrence was over 50 years old, and the effect was not seen using BV as an antitumor agent (subgroup of RPA class 7) 4. Patients who have confirmed the following in MRI images taken within 28 days prior to BNCT therapy - Case where the tumor is confined to the one side hemisphere on the supratentorial area, the deepest part is within 60 mm from the scalp (Even if the deepest part is 60 mm or more, cases that are judged to be irradiable by air substitution to the tumor excision cavity are indicated as adaptation). - It is single-shot and does not allow seeding. 5. Patients who aged 15 years or older and under 85 years of age at the time of acquiring consent. 6. Patients with KPS of 60% or more 7. Patients who are expected to survive more than 3 months at the time of acquiring consent 8. Patients with bone marrow, liver, kidney function satisfying the following conditions within 28 days before enrollment - Leukocyte count 3,000 /microlitter or more, Neutrophil count 1,500 /microlitter or more, Hemoglobin 8.0 g/dL or more, Platelet count 100,000 /microlitter or more, AST 100 IU/L or less, ALT 100 IU/L or less, Total bilirubin 1.5 mg/dL or less, Serum creatinine 1.2 mg/dL or less, Urine protein 1+ or less, PT-INR 1.6 or less 9. Patient's consent to participate in this study was obtained in writing from the patient himself
Exclusion criteria
Exclusion criteria: 1. Patients suspected of cerebral radiation necrosis at enrollment 2. Patients with infections requiring intravenous administration such as antibiotics, antivirals, antifungal drugs 3. Patients with fever (over 38C) 4. Patients with serious complications / previous medical history - Unstable angina pectoris, myocardial infarction complications, past within 6 months - Digestive ulcer with poor control - Poor control hypertension, diabetes - Advanced wounds that are not approved for healing, traumatic fractures - Digestive tract perforation, fistula, abdominal abscess complications, past within 6 months - Complication of CTCAE Grade 2 or higher pulmonary hemorrhage (hemoptysis [excretion of occult blood over 2.5 ml]), past history - Complication of vascular disorders (venous / arterial thrombus, embolism, aortic aneurysm) requiring treatment, past within 6 months - Complication of congestive heart failure of II degree or more in NYHA - Pulmonary fibrosis / interstitial pneumonia requiring treatment (CTCAE Grade 2 or higher) - Patients scheduled for surgery during the study or patients under 4 weeks from surgical therapy 5. Patients with phenylketonuria 6. Current bleeding (intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage, retroperitoneal hemorrhage, hemoptysis, etc.) 7. Under anticoagulant medication, control is unstable or PT-INR is more than 2.5 8. Severe hypersensitivity to components of BPA and BV 9. Pregnant woman or lactating woman 10. Patients who do not agree to contraception participating in this study 11. Patients who participated in other clinical trials within one month prior to acquiring consent 12. Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival OS: It is defined as the period from the treatment start date to the death date due to any cause. In surviving cases, we will terminate halfway with the date of final survival confirmation. In the case of non-follow-up cases, we aborted by the last day that survival was confirmed before becoming impossible to pursue. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS by RANO standard: It is defined as the period from the treatment start date to the day when the progression of disease (PD) based on the RANO standard, or until the death date due to any cause. In cases that did not deteriorate, we abort halfway with the final progression-free evacuation date (the date of making a decision other than deterioration). In the case of non-follow-up cases, we abort halfway with the final progression-free confirmation date before becoming impossible to pursue. Expression of adverse events: Evaluate adverse events and serious adverse events that occurred during treatment or within 30 days after the end of treatment. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0). | — |
Countries
Japan
Contacts
Public ContactShin-Ichi Miyatake
Osaka Medical College Department of Neurosurgery
Outcome results
None listed