UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003773 |
|---|---|
| Receipt number | R000004571 |
| Scientific Title | Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy. |
| Date of disclosure of the study information | 2010/06/21 |
| Last modified on | 2014/07/10 16:55:41 |
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Basic information
Public title
Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.
Acronym
Peptid vaccination to prevent recurrence of HCV-positive liver cancer.
Scientific Title
Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.
Scientific Title:Acronym
Peptid vaccination to prevent recurrence of HCV-positive liver cancer.
Region
| Japan |
Condition
Condition
liver cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Object of the study is to investigate safety of peptide-cocktail vaccines consist of 10 cancer-derived peptides and 3 HCV-derived peptides emulsified with incomplete Freund's adjuvant.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety, to evaluate with CTCAE v4.0
Key secondary outcomes
Immunological responses (anti-peptide IgG)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
<Treatment with 6 times, every weeks>
Interview : Day1, 8, 15, 22, 29, 36
Treatment : Day1, 8, 15, 22, 29, 36
Watching adverse events : Day1, 8, 15, 22, 29, 36
Immune function test : Day36
Blood test : Day36
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1)HCV-positive patients with liver cancer who have undergone radical therapy and no legion has been confirmed by ultrasonography and/or CT.
2) Patients must be at a score level
0~1 of performance status (PS) (ECOG).
3) Patients must satisfy the followings:
WBC is more than 2,200/mm3
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dL
Platelet is more than 50,000/mm3
Serum Creatinine is less than 2.0mg/dL
Total Bilirubin is less than 2.5mg/dL
4) Patients must be at a total score level 7 or less of Child-Pugh
5) Patients must be more 20 year-old or more to 80 years old or less.
6)Patients must be expected to survive more than 3 months.
7) Written informed consent must be obtained from patients.
Key exclusion criteria
The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2)Patients with multiple active cancers
3)Patients suspected with immunodeficiency and opportunistic infection.
4) Patients with the past history of severe allergic reactions.
5)Patients who are during pregnancy, lactation expectant, and desiring future fertility.
6)Patients with a score II or more of hepatic encephalopathy.
7) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL
0942-27-5210
yutani@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7572
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Cancer Vaccine Center
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 21 | 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
| 2010 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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 | 06 | Month | 17 | Day |
Last modified on
| 2014 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004571
