Recurrent malignant brain tumor
Conditions
Interventions
1)Boron compounds 250mg/kg of boronopehnylalanine, dose escalation was possible 2)Neutron irradiation Less than 12Gy-Eq for normal brain and skin dose.
Sponsors
Department of Neurosurgery Institute of Clinical Medicine Graduate School of Comprehensive Human Sciences University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Agaed 15 and over, and 70 and under. Diagnosed as recurrent malignant glioma, recurrent malignant /anaplastic meningioma, malignant melanoma, and metastatic brain tumor or skull base tumor with no standard therapies. 2) Karnofsky Performance Scale(KPS) >50% 3) Enhance lesion locate within cerebral hemisphere. Infratentorial lesions without untreated hydrocephalus or brain stem compression. 4) The target lesion is located within 7cm from the brain surface. 5) Informed about their diagnosis. 6) course observation is possible.
Exclusion criteria
Exclusion criteria: 1)Patient with dissemination. 2)AST,ALT > 100IU/ml , Bilirubin > 2.0mg% BUN > 30mg/dl , Cr > 1.8mg% WBC < 2500/mm3 , Plt < 75000/mm3 , Hb < 8g/dl 3)irradiated > 70Gy-Eq to the lesion or normal brain tissue as a previous treatment. 4)There are other malignanicies. 5)The patients with phenylcetonuria. 6)Patients who have complications that are considered inappropriate for the trial. 7)Responsible doctors judged the patient inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Tumor control rate, local control rate QOL, neurological function | — |
Countries
Japan
Contacts
Public ContactKei Nakai
Institute of Clinical Medicine Graduate School of Comprehensive Human Sciences University of Tsukuba Department of Neurosurgery
Outcome results
None listed