UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005528 |
|---|---|
| Receipt number | 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 01:06:25 |
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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
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
nkagawa@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006556
