Unique ID issued by UMIN | UMIN000013419 |
---|---|
Receipt number | R000015651 |
Scientific Title | Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab |
Date of disclosure of the study information | 2014/03/14 |
Last modified on | 2014/03/14 13:49:59 |
Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab
BNCT plus bevacizumab for recurrent malignant gliomas
Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab
BNCT plus bevacizumab for recurrent malignant gliomas
Japan |
recurrent malignant glioma
Radiology | Neurosurgery |
Malignancy
NO
A phase I, II, clinical trial for high-risk recurrent malignant gliomas (RPA class 3+7) using boron neutron capture therapy and bevacizumab
Safety,Efficacy
Exploratory
Phase I,II
Overall survival
Tumor response
Incidence of radiation necrosis and/or pseudoprogression
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
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 given biweekly with 10mg/kg as long as progressive disease judged by RANO criteria.
Here: RPA class 3 is non-GBM as initial histology and poor KPS less than 70%. RPA class 7 is GBM as initial histology, age more than 50 and steroids required to maintain ADL. The MST of these classes is reported as 4.4 months after the recurrence.
10 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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.
50
1st name | |
Middle name | |
Last name | Shin-Ichi Miyatake |
Osaka Medical College
Department of Neurosurgery
Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686
072-683-1221
neu070@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Shin-Ichi Miyatake |
Osaka Medical College
Department of Neurosurgery
Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686
072-683-1221
neu070@poh.osaka-med.ac.jp
Dept. of Neurosurgery, Osaka Medical College
Osaka Medical College
Self funding
NO
2014 | Year | 03 | Month | 14 | Day |
Unpublished
Preinitiation
2014 | Year | 01 | Month | 31 | Day |
2014 | Year | 03 | Month | 20 | Day |
2014 | Year | 03 | Month | 14 | Day |
2014 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015651