UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002990 |
|---|---|
| Receipt number | R000003626 |
| Scientific Title | Phase I/II clinical trial of WT1 peptide vaccine for the children with malignancies |
| Date of disclosure of the study information | 2010/01/12 |
| Last modified on | 2013/07/19 05:22:01 |
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Basic information
Public title
Phase I/II clinical trial of WT1 peptide vaccine for the children with malignancies
Acronym
WT1 peptide vaccination to the children with malignancies
Scientific Title
Phase I/II clinical trial of WT1 peptide vaccine for the children with malignancies
Scientific Title:Acronym
WT1 peptide vaccination to the children with malignancies
Region
| Japan |
Condition
Condition
pediatric acute leukemia or pediatric malignant solid tumors
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety and efficacy of modified WT1-peptide vaccination
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event rate (phase I) and anti-tumor effect (phase II)
Key secondary outcomes
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
| Vaccine |
Interventions/Control_1
WT1 peptide + montanide adjuvant. every week x 12 times (= 3 months).
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
<main inclusion criteria>
Tumor cells: WT1 expression (+).
HLA: A2402(+).
Residual tumor or tumor marker (+),
or high risk of relapse.
Others.
Key exclusion criteria
<main exclusion criteria>
MDS and/or MPN before allogeneic HSCT.
Inappropriate condition.
Others.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisei Kawa |
Organization
Osaka Medical Center and Research Institute for
Maternal and Child Health
Division name
Director of Hospital
Zip code
Address
840 Murodo, Izumi City, Osaka 594-1101
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa Sawada |
Organization
Osaka Medical Center and Research Institute for
Division name
Hematology/Oncology
Zip code
Address
840 Murodo, Izumi City, Osaka 594-1101
TEL
Homepage URL
Sponsor or person
Institute
Osaka Medical Center and Research Institute for
Maternal and Child Health
Institute
Department
Personal name
Funding Source
Organization
Childhood Cancer Association, Japan (CCAJ), etc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical and Dental University, etc.
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
| 2010 | Year | 01 | Month | 12 | 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
Completed
Date of protocol fixation
| 2004 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 07 | Day |
Last modified on
| 2013 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003626
