UMIN-CTR Clinical Trial

Public title

Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab

Acronym

BNCT plus bevacizumab for recurrent malignant gliomas

Scientific Title

Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab

Scientific Title:Acronym

BNCT plus bevacizumab for recurrent malignant gliomas

Region

Japan

Condition

recurrent malignant glioma

Classification by specialty

Radiology

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

A phase I, II, clinical trial for high-risk recurrent malignant gliomas (RPA class 3+7) using boron neutron capture therapy and bevacizumab

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Overall survival

Key secondary outcomes

Tumor response
Incidence of radiation necrosis and/or pseudoprogression

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

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.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

10

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Shin-Ichi Miyatake

Organization

Osaka Medical College

Division name

Department of Neurosurgery

Zip code

Address

Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686

TEL

072-683-1221

Email

neu070@poh.osaka-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Shin-Ichi Miyatake

Organization

Osaka Medical College

Division name

Department of Neurosurgery

Zip code

Address

Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686

TEL

072-683-1221

Homepage URL

Email

neu070@poh.osaka-med.ac.jp

Institute

Dept. of Neurosurgery, Osaka Medical College

Institute

Department

Personal name

Organization

Osaka Medical College

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

03

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2014

Year

01

Month

31

Day

Date of IRB

Anticipated trial start date

2014

Year

03

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

14

Day

Last modified on

2014

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015651