Unique ID issued by UMIN | UMIN000003590 |
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Receipt number | R000004353 |
Scientific Title | Phase II clinical trial of personalized peptide vaccination for standard therapy failed liver cancer patients. (except HCV positive patients in stage IV) |
Date of disclosure of the study information | 2010/05/10 |
Last modified on | 2017/11/13 15:49:13 |
Phase II clinical trial of personalized peptide vaccination for standard therapy failed liver cancer patients. (except HCV positive patients in stage IV)
Randomized Phase II study of peptide vaccination for liver cancer.
Phase II clinical trial of personalized peptide vaccination for standard therapy failed liver cancer patients. (except HCV positive patients in stage IV)
Randomized Phase II study of peptide vaccination for liver cancer.
Japan |
liver cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to standard therapy failed liver cancer patients (except HCV positive patients in stage IV). The aim of the study is to investigate immunological responses.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
1. Evaluation of long-term prognosis (progression free survival and total survival).
2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Vaccine |
(1st treatment: total 6 times, every weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 45: Final evaluation.
The 1st treatment (total 6 times, every weeks) is finished
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as standard therapy failed liver cancer.except HCV positive patients in stage IV)
2) Patients must be at a score level
0~1 of performance status (PS) (ECOG).
3) Patients must have IgG reactive to at least two of candidate peptides.
4)Patients must be expected to survive more than 3 months.
6) Patients must satisfy the followings:
WBC is more than 2,500/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
6) Patients must be more 20 year-old.
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.
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 the past history of severe allergic reactions.
3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4) Patients who are judged inappropriate for the clinical trial by doctors.
100
1st name | |
Middle name | |
Last name | Shigeru Yutani |
Kurume University
Cancer Vaccine Center
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
0942-27-5210
yutani@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
0942-31-7572
akiymd@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
None
Other
NO
2010 | Year | 05 | Month | 10 | Day |
Unpublished
Completed
2010 | Year | 05 | Month | 07 | Day |
2010 | Year | 05 | Month | 08 | Day |
2010 | Year | 05 | Month | 10 | Day |
2017 | Year | 11 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004353
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