UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005312 |
|---|---|
| Receipt number | R000006307 |
| Scientific Title | A pilot trial of immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy. |
| Date of disclosure of the study information | 2011/03/25 |
| Last modified on | 2014/02/25 00:10:51 |
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Basic information
Public title
A pilot trial of immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Acronym
A pilot trial of immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Scientific Title
A pilot trial of immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Scientific Title:Acronym
A pilot trial of immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Region
| Japan |
Condition
Condition
Osteosarcoma
Soft tissue sarcoma
neuroblastoma
Pediatric bone, soft tissue sarcoma at high risk of recurrence.
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of WT1 peptide vaccination for pediatric malignant patients after conventional chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Time to progression from the end of conventional chemotherapy.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
See Japanese protocol or ask directly to us.
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
See Japanese protocol or ask directly to us.
Key exclusion criteria
See Japanese protocol or ask directly to us.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikio Hashii |
Organization
Osaka University
Division name
Pediatrics
Zip code
Address
2-2, Yamadaoka Suita
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 univ
Division name
Pediatrics
Zip code
Address
2-2, Yamadaoka Suita
TEL
06-6879-3932
Homepage URL
areken@ped.med.osaka-us.jp
Sponsor or person
Institute
Osaka Universty
Institute
Department
Personal name
Funding Source
Organization
Osaka University
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
大阪大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | 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=R000006307
