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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005312
Receipt No. 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

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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
Email 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
Email areken@ped.med.osaka-us.jp

Sponsor
Institute Osaka Universty
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006307

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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