UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013252 |
|---|---|
| Receipt number | 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 00:05:20 |
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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
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
areken@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003503
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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