Unique ID issued by UMIN | UMIN000005634 |
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Receipt number | R000006657 |
Scientific Title | Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer. |
Date of disclosure of the study information | 2011/05/24 |
Last modified on | 2014/06/24 14:24:49 |
Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
Phase II study of peptide vaccination in HCV positive patients with advanced liver cancer.
Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
Phase II study of peptide vaccination in HCV positive patients with advanced 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 the safety, immunological responses and antitumor activity.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Evaluation of antitumor activity (overall survival) of peptide vaccination.
1.Evaluation of response rate and long-term prognosis (overall survival).
2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0).
3.Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Vaccine |
personalized peptide vaccine plus best supportive care (BSC)
( total 8 times, every 1 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, 43, 50: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 50: Final evaluation.
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, corticosteroids, and transfusion) during the vaccination.
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions.
1) HCV positive patients with standard therapy failed stage VI liver cancer.
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 in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
6) Patients must satisfy the followings:
WBC is more than 2,000/mm3
Lymphocyte is more than 900/mm3
Hb is more than 8.0g/dl
Platelet is more than 40,000/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) Patients must be expected to survive more than 3 months.
8) Written informed consent must be obtained from patients.
9) Prior treatment are allowed and must complete before random assignment with full recovery of related toxicity.
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)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3) Patient who has doubt of immune deficiency disease or opportunistic infection.
4) Patients with the past history of severe allergic reactions.
2) Women during pregnancy or breast-feeding.
6) Patient of hepatic encephalopathy two degrees or more
7) Patients with brain metastasis.
8) Patients who are judged inappropriate for the clinical trial by doctors.
41
1st name | |
Middle name | |
Last name | Shigeru Yutani |
Kurume University
Department of Immunology and Immunotherapy
Asahi-machi 67, Kurume, Fukuoka 830-0011
0942-31-7551
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
0942-31-7572
akiymd@med.kurume-u.ac.jp
Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Japan
Hirosaki University , Fukusima prefectural medical University, Showa University, Kinki University
Kurume University
NO
久留米大学病院(福岡県)、弘前大学病院(青森県)、福島県立医科大学病院(福島県)、昭和大学病院(東京都)、近畿大学病院(大阪府)Kurume University Hosipital, Hirosaki University Hospital, Fukusima prefectural medical University Hospital, Showa University Hospital, Kinki University Hosipital
2011 | Year | 05 | Month | 24 | Day |
Unpublished
Completed
2011 | Year | 02 | Month | 22 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 24 | Day |
2014 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006657
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