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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013252
Receipt No. R000003503
Scientific Title WT1 peptide vaccination for pediatric patients: phase I/II study.
Date of disclosure of the study information 2014/02/25
Last modified on 2014/02/25

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Basic information
Public title WT1 peptide vaccination for pediatric patients: phase I/II study.
Acronym WT1 peptide vaccination for pediatric patients:tumor regression study.
Scientific Title WT1 peptide vaccination for pediatric patients: phase I/II study.
Scientific Title:Acronym WT1 peptide vaccination for pediatric patients:tumor regression study.
Region
Japan

Condition
Condition pediatric malignant tumor, hematological malignancy
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this clinical trial is the effectiveness and the safety of the immunity medical treatment by the WT1 peptide for an pediatric malignant tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes The frequency of side effect. The effectivness
Key secondary outcomes WT1specific immunological reaction

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 Vaccine
Interventions/Control_1 The patient is intradermally injected with 0.5-3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination is scheduled to be performed 12 times at weekly intervals( phase 1). The safety and efficacy are evaluated by the NCI-CTC and RECIST criteria after 12th WT1 vaccination (phase 2). If no SAE, the vaccination is continued bi-weekly or 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
20 years-old >
Gender Male and Female
Key inclusion criteria Residual tumor is confirmed by Image after conventional therapy.
HLA A2402
Wt1 positive pathologilally
NCI-CTC grade 1
ps 0 to 2
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
Target sample size 20

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 Department of Developmental Medicine (Pediatrics),
Zip code
Address 2-2, Yamada-oka, Suita City, Osaka , Japan
TEL 06-6879-3932
Email areken@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 Department of Developmental Medicine (Pediatrics),
Zip code
Address 2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL 06-6879-3932
Homepage URL
Email areken@ped.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid from the Ministry of Education, Science and Culture of Japan
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 25 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2006 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 24 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 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003503

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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