UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003207 |
|---|---|
| Receipt number | R000003888 |
| Scientific Title | Phase I study of peptide vaccination for patients with biliary tract cancer |
| Date of disclosure of the study information | 2010/02/19 |
| Last modified on | 2011/04/26 12:40:36 |
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Basic information
Public title
Phase I study of peptide vaccination for patients with biliary tract cancer
Acronym
Phase I study of peptide vaccination for patients with biliary tract cancer
Scientific Title
Phase I study of peptide vaccination for patients with biliary tract cancer
Scientific Title:Acronym
Phase I study of peptide vaccination for patients with 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 in patients with refractory 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
3
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Patients will be vaccinated once a week for four weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted A1589 peptide(0.5mg), A3243 peptide(0.5mg), B5860N peptide(0.5mg), C7457 peptide(0.5mg) mixed with Montanide ISA-51 will be administered by subcutaneous injection.
Interventions/Control_2
Patients will be vaccinated once a week for four weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted A1589 peptide(1mg), A3243 peptide(1mg), B5860N peptide (1mg), C7457 peptide(1mg) mixed with Montanide ISA-51 will be administered by subcutaneous injection.
Interventions/Control_3
Patients will be vaccinated once a week for four weeks of a treatment cycle. ON each vaccination day, the HLA-A*2402 restricted A1589 peptide(2mg), A3243 peptide(2mg), B5860N peptide(2mg), C7457 peptide(2mg) mixed with Montanide ISA-51 will be administered by subcutaneous injection.
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
9
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
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
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 19 | 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
| 2007 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 18 | Day |
Last modified on
| 2011 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003888
