Pancreatic cancer
Conditions
Interventions
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
Sponsors
Kurume University Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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)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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between two groups of immune-enhancing effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison between two groups of long-term prognosis. 2. Comparison between two groups of adverse,safety of peptide vaccination | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Outcome results
None listed