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
Sponsors
Dept. of Neurosurgery, Osaka Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients with definitive diagnosis of recurrent malignant gliomas by histopathology 2 Highly suspect of recurrent malignant glioma on MRI and amino-acid PET (At least 1 or 2 should be fulfilled.) 3 RPA class 3 : non-GBM as initial histology and poor KPS less than 70%. 4 RPA class 7 : GBM as initial histology, age more than 50 and steroids required to maintain ADL (candidate should belong to 3 or 4) 5 The tumor locates at a supra-tentorial hemisphere. The deepest part of the tumor should be less than 6 cm from the scalp. Even if the bottom of the tumor is more than 6 cm from the scalp, the patients may be included in the study, if the air instillation into tumor-removed cavity is possible. 6 Life expectancy is more than 3 months. 7 Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration. a) Leukocyte count more than 3,000 /microL b) Hemoglobin level more than 8.0 g/dL c) Platelet countmore than 10.0 x 104 /microL d) Serum creatine levelless than 1.5 mg/dL e) ALT levels less than 100 IU/L f) AST levels less than 100 IU/L 8 Patients who agreed to participate in this clinical study in writing after receiving sufficient explanation.
Exclusion criteria
Exclusion criteria: 1) Female patients in definitive or possible pregnancy or in breast-feeding. 2) Patients with phenylketonuria. 3) Patients with grade 3 or 4 in NYHA classification. 4) Patients with cerebrospinal fluid dissemination. 5) Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response Incidence of radiation necrosis and/or pseudoprogression | — |
Countries
Japan
Contacts
Public ContactShin-Ichi Miyatake
Osaka Medical College Department of Neurosurgery
Outcome results
None listed