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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005127
Receipt No. R000006096
Scientific Title Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer
Date of disclosure of the study information 2011/02/23
Last modified on 2015/06/25

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Basic information
Public title Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer
Acronym Peptide vaccination with CpG for unresectable biliary tract cancer
Scientific Title Phase I study of peptide vaccination with CpG for patients with unresectable biliary tract cancer
Scientific Title:Acronym Peptide vaccination with CpG for unresectable biliary tract cancer
Region
Japan

Condition
Condition biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the safety and specific immune responses on peptide vaccination with CpG in patients with unresectable biliary tract cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Assessment of safety
Key secondary outcomes Assessment of specific immune response

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Patients will be vaccinated once a week for eight weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted FOXM1 peptide(2mg), MELK peptide(2mg), HJURP peptide(2mg), VEGFR1 peptide(2mg), VEGFR2 peptide(2mg) mixed with Montanide ISA-51 will be administered by subcutaneous injection.
Interventions/Control_2 Patients will be vaccinated once a week for eight weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted FOXM1 peptide(2mg), MELK peptide(2mg), HJURP peptide(2mg), VEGFR1 peptide(2mg), VEGFR2 peptide(2mg) mixed with CpG (1mg) plus Montanide ISA-51 will be administered by subcutaneous injection.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Clinically or pathologically diagnosed biliary tract cancer
2.Age between 20 to 80
3.Life expectancy > 3 months
4.No severe organ function impairment
5.Patients who have unresectable tumors to be refractory to chemotherapy
6.Written informed consent of the patient
7.Performance Status 0-2
Key exclusion criteria 1.Pregnancy or lactation
2.Decision of unsuitableness by principal investigator
3.Patient with severe underlying disease
4.Patient with severe allergy disease
Target sample size 10

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 Gastroenterological Surgery
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email yamamoto@ige.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Aruga
Organization Tokyo Women's Medical University
Division name Institute of Advanced Biomedial Engineering and Science
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku. Tokyo
TEL 03-3353-8111
Homepage URL
Email aruga.atsushi@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Human Genome Center, Institute of Medical Science, The University of Tokyo
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 東京女子医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 23 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
2011 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 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
2011 Year 02 Month 23 Day
Last modified on
2015 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006096

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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