Unique ID issued by UMIN | UMIN000006295 |
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Receipt number | R000007425 |
Scientific Title | Phase II clinical trial of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable. |
Date of disclosure of the study information | 2011/09/06 |
Last modified on | 2016/12/26 17:36:48 |
Phase II clinical trial of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable.
Phase II study of peptide vaccination for Pancreatic cancer patients.
Phase II clinical trial of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable.
Phase II study of peptide vaccination for Pancreatic cancer patients.
Japan |
Pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The aim of study is to investigate safety , immunity-enhancing , clinical effect of combination of personalized peptide vaccination and Juzen-taiho-to for Pancreatic cancer patients who failed standard therapy or unresectable.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Comparison between two groups of immune-enhancing effects.
1. Comparison between two groups of long-term prognosis.
2. Comparison between two groups of adverse,safety of peptide vaccination
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Medicine | Vaccine |
arm1:
Start date to the sixth administration of the peptide vaccine, by mouth three times a day Juzentaihoto. The amount of oral once 5g.
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with adjuvant and subcutaneously inject (3.0 mg/peptide)( total 6 times, every 1 weeks).
arm2:
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with adjuvant and subcutaneously inject (3.0 mg/peptide)( total 6 times, every 1 weeks).
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as Pancreatic cancer of the standard therapy failed or the unresectable.
Presence of target lesion is not considered.
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 must be expected to survive more than 3 months.
5) 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, A24, A26, A3, A11, A31 or A33.
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) Patients with the past history of severe allergic reactions.
4) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility.
(Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
5) Patients who are judged inappropriate for the clinical trial by doctors.
60
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
0942-31-7744
akiymd@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
None
Other
NO
2011 | Year | 09 | Month | 06 | Day |
Unpublished
Completed
2011 | Year | 07 | Month | 22 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 06 | Day |
2016 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007425
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