UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004333 |
|---|---|
| Receipt number | R000005192 |
| Scientific Title | Phase I study of peptide vaccination with GM-CSF for unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2010/10/06 |
| Last modified on | 2012/10/31 15:52:46 |
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Basic information
Public title
Phase I study of peptide vaccination with GM-CSF for unresectable hepatocellular carcinoma
Acronym
Phase I study of peptide vaccination with GM-CSF for unresectable hepatocellular carcinoma
Scientific Title
Phase I study of peptide vaccination with GM-CSF for unresectable hepatocellular carcinoma
Scientific Title:Acronym
Phase I study of peptide vaccination with GM-CSF for unresectable hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
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 clinical responses on peptide vaccination with GM-CSF for unresectable hepatocellular carcinoma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Assessment of safelty
Key secondary outcomes
Assessment of clinilal responses
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 eight weeks of a treatment cycle. On each vaccination day, VEGFR1, VEGFR2, GPC3 peptide(2mg) mixed with GM-CSF(10microgram) and 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, VEGFR1, VEGFR2, GPC3 peptide(2mg) mixed with GM-CSF(25microgram) and Montanide ISA-51 will be administered by subcutaneous injection.
Interventions/Control_3
Patients will be vaccinated once a week for eight weeks of a treatment cycle. On each vaccination day, VEGFR1, VEGFR2, GPC3 peptide(2mg) mixed with GM-CSF(50microgram) and 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.HLA-A*2402 positive patients with clinically or pathologically diagnosed unresectable hepatocellular carcinoma.
2.Age between 20 to 80
3.No severe organ function impairment
4.Written informed consent of the patient
5.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, Shinjyuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Kotera |
Organization
Tokyo Women's Medical University
Division name
Department of Gastroenterological Surgery
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（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 06 | 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
| 2009 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2012 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005192
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| Registered date | File name |
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| Registered date | File name |
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