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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013258
Receipt No. R000015460
Scientific Title Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Date of disclosure of the study information 2014/02/26
Last modified on 2014/05/15

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Basic information
Public title Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Acronym Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Scientific Title Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Scientific Title:Acronym Phase II clinical trial of WT1 peptide-based vaccine for pediatric patients with recurrent malignant glioma
Region
Japan

Condition
Condition Malignant Glioma DIPG
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 his study is undertaken to evaluate anti-tumor effects of an immunotherapy using WT1 peptide against recurrent high grade glioma or diffuse intrinsic pontine glioma. Patients to be recruited must bear at least one copy of either HLA-A*0201, or A*2402.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes One year survival ratio
Key secondary outcomes Effectiveness using RANO criteria,
Safty,
immunomonitaring to WT1 peptide

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 The patient is intradermally injected with 0.5 -2 mg of the HLA-A2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN), the HLA A0201 restricted (mp126-134 RMFPNAPYL) modified WT1 peptide and WT1 helper peptide (p332-347 KRYFKLSHLQMHSRKH) emulsioned with Montanide ISA51 adjuvant.The WT1 vaccination was scheduled to be performed 6 times by-weekly intervals. Intradermally injection of WT1 vaccine will be continued for 1 year monthly.
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

Not applicable
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1) Pathologically confirmed high grade glioma except diffuse intrinsic pontine glioma
2) WT1 pathologically positive in HGG.
3) Recurrence confirmed with RANO criteria including radiological evaluations.
4) From 1 month after completion of radiotherapy
5) ECOG-PS: 0-3
6) Age:under 15 years old
7) HLA-A*24:02 and / or HLA-A*02:01
8) adequate organ functions
Neutrophils > 1,000
Platelets > 25, 000
Hb > 6.5
sCr : Age normal level upper limit 3 times
T-Bil : Age normal level upper limit 3 times
AST / ALT < 200 IU/L
9) Informed consent from legal guardian
Key exclusion criteria 1) active infectious diseases
2) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on
3) Other severe problems unsuitable for this study active infectious diseases
4) Active other cancers except for carcinoma in situ treated completely
5) Past history of Myeloproliferative diseases, MSD
6) Received allogeneic stem cell transplantation
7) Severe Psychological Problems
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiko Hashii
Organization Osaka university graduate school of medicine
Division name Pediatrics
Zip code
Address 2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL 06-6879-3932
Email yhashii@ped.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Hashii
Organization Osaka university graduate school of medicine
Division name Pediatrics
Zip code
Address 2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL 06-6879-3932
Homepage URL
Email yhashii@ped.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
Institute
Department

Funding Source
Organization The Japanese Ministries of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 26 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 Preinitiation
Date of protocol fixation
2014 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 07 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
2014 Year 02 Month 25 Day
Last modified on
2014 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015460

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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