UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002771 |
|---|---|
| Receipt number | R000003372 |
| Scientific Title | Phase I clinical trial of Wilms tumor 1 peptide vaccination for patients with advanced cancer |
| Date of disclosure of the study information | 2009/11/17 |
| Last modified on | 2011/11/17 11:34:25 |
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Basic information
Public title
Phase I clinical trial of Wilms tumor 1 peptide vaccination for patients with advanced cancer
Acronym
Phase I clinical trial of Wilms tumor 1 peptide vaccination
Scientific Title
Phase I clinical trial of Wilms tumor 1 peptide vaccination for patients with advanced cancer
Scientific Title:Acronym
Phase I clinical trial of Wilms tumor 1 peptide vaccination
Region
| Japan |
Condition
Condition
advanced cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of safty of WT1 peptide vaccination with / without adjuvant (GM-CSF or CpG)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safty of WT1 peptide vaccination with / without adjuvant (GM-CSF or CpG)
Key secondary outcomes
Efficacy of WT1 peptide vaccination with / without adjuvant (GM-CSF or CpG)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
WT1 peptide
Interventions/Control_2
GM-CSF
Interventions/Control_3
CpG
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
WT1 expression in cancer cells
HLA-A2402, A0201, A0206
No severe organ function impairment
Written informed consent of the patient
Performance Status 0-2
Key exclusion criteria
Pregnant female
Patient with severe underlying disease
Patient with severe allergy disease
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamamoto |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ohno |
Organization
Waseda University
Division name
Consolidated Research Institute for Advanced Science and Medical Care
Zip code
Address
513, Wasedatsurumaki-cho, Shinjuku-ku, Tokyo
TEL
Homepage URL
ohno55@aoni.waseda.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 17 | 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
| 2009 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | 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
| 2009 | Year | 11 | Month | 17 | Day |
Last modified on
| 2011 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003372
