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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005528
Receipt No. R000006556
Scientific Title A clinical study of Bevacizumab therapy in combination with chemotherapeutic drugs for children with recurrent glioma
Date of disclosure of the study information 2011/04/29
Last modified on 2015/05/01

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Basic information
Public title A clinical study of Bevacizumab therapy in combination with chemotherapeutic drugs for children with recurrent glioma
Acronym Bevacizumab plus chemotherapy for children with recurrent glioma
Scientific Title A clinical study of Bevacizumab therapy in combination with chemotherapeutic drugs for children with recurrent glioma
Scientific Title:Acronym Bevacizumab plus chemotherapy for children with recurrent glioma
Region
Japan

Condition
Condition recurrent malignant glioma in children
Classification by specialty
Hematology and clinical oncology Pediatrics Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and efficacy of the combination of Bevacizumab and chemotherapeutic drugs for children with recurrent malignant gliomas
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes progression free survival, objective tumor response, response rate
Key secondary outcomes overall survival, incidence of adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Both Bevacizumab and irinotecan is administered intravenously over 90 minutes, once every 2 weeks: day 1, 15 of a 4-week cycle. Bevacizumab dose is 10mg/kg and ironotecan dose is 340/m2 in patients on enzyme-inducing antiepileptic drugs or 125mg/m2 in the others.Treatment with the same doses of bevacizumab and irinotecan is repeated every 2 weeks until the occurrence of grade 3 or 4 toxicity or tumor progression. Patients were allowed a one-time 25% dose reduction of irinotecan for grade 3 or 4 gastrointestinal toxicity.
If adverse events are not improved, tomozolomide or oral VP-16 is selected as chemotherapeutic agents. Chemotherapy with temozolomide is done according to Stupp regimen.
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

Eligibility
Age-lower limit
0 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria The subjects must satisfy the following conditions.
1) Patients histopathologically or radiologically diagnosed as recurrent malignant glioma in children.
2) Performance Status is 2 or less, and 3 in cases with neurological deficits.
3) Karnofsky Performance Status is at least 40%.
4) Patient's data from blood sample must satisfy the followings:
Neutrophil: more than 1500/mm3
Hb: more than 7.0g/dl
Platelet: more than 100,000/mm3
5) At least one month since prior anticancer therapy
6) No residual hemorrhagic lesions
7) Written informed consent must be obtained from patients or legally acceptable representatives.
Key exclusion criteria The following patients must be excluded:
1)Patients taking anticoagulant agents
2)Patients with the past history of thrombosis
3)Patients with the past history of intestinal hemorrhage or lung hemorrhage
4)Past history of stereotactic radiosurgery for intracranial lesions may be included in exclusion criteria.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Kagawa
Organization Osaka University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3652
Email nkagawa@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Kagawa
Organization Osaka University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3652
Homepage URL
Email nkagawa@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2011 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 29 Day
Last modified on
2015 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006556

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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