Phase II clinical trial on clinical efficacy and safety of combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis
- Conditions
- Recurrent malignant glioma
- Registration Number
- JPRN-UMIN000029144
- Lead Sponsor
- Osaka Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).