Unique ID issued by UMIN | UMIN000003520 |
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Receipt number | R000004272 |
Scientific Title | Randomized Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer. |
Date of disclosure of the study information | 2010/04/22 |
Last modified on | 2014/06/24 14:22:02 |
Randomized Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
Randomized Phase II study of peptide vaccination in HCV positive patients with advanced liver cancer.
Randomized Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
Randomized 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 32 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to HCV positive patients with standard therapy failed stage VI liver cancer. 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
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine | Vaccine |
Arm 1: personalized peptide vaccine plus best supportive care (BSC)
(1st treatment: 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: First evaluation.
(2nd treatment: total 8 times, every 2 weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides.
Day 15, 29, 43, 57, 71, 85, 99 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 99: Second evaluation.
(3rd treatment: total times, every 2 weeks)
Day 15, 29, 43, 57, 71, 85, 99 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 99: Third evaluation.
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, corticosteroids, and transfusion) during the vaccination.
Arm 2: Best supportive care (BSC) BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, orticosteroids, and transfusion) for 40 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must be satisfactory 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 ECOG performance status.
3) patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types.
4) Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
5) Patients must satisfy the followings.
WBC is more than 2500 per mm3
Lymphocyte is more than 1000 per mm3
Hb is more than 8.0 g per dL
Platelet is more than 80000 per mm3
Serum creatinine is less than 2.0 mg/dl
Total bilirubin is less than 2.5 mg/dl
6) patients must be more than 20 years 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) Patients with the past history of severe allergic reactions.
3) Patients who are during pregnancy, lactation expectant, and desiring future fertility.
4) Patients who are judged inappropriate for the clinical trial by doctors.
84
1st name | |
Middle name | |
Last name | Shigeru Yutani |
Kurume University
Department of Immunology and Immunotherapy
Asahi-machi 67, Kurume, Fukuoka 830-0011
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 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
2010 | Year | 04 | Month | 22 | Day |
Unpublished
Completed
2010 | Year | 03 | Month | 05 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 22 | Day |
2014 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004272
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