Castration-resistant prostate cancer
Conditions
Interventions
1st cycle: (Personalized peptide vaccination alone) 4 peptide vaccines are selected from 31 peptide candidates restricted by HLA-class I, to which peptide-specific IgGs are detected before vaccinati
Sponsors
Cancer Vaccine Center, Kurume University School of medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as prostate cancer pathologically at the initial treatment. The patients must be suffering from castration-resistant prostate cancer after standard treatment. 2) Patients have not been diagnosed as diabetes, and patients must satisfy the followings: HbA1c < and = 6.5% Patients do not receive medical therapy using the diabetes medicine (including an oral hypoglycemic drug, the insulin therapy). 3) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 4) Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type. 5) Patients must have IgG reactive to at least two of peptide the candidate peptides restricted to the patient's HLA types. 6) Patients must satisfy the followings: WBC >and= 2,500/mm3 Lymphocyte >and=1,000/mm3 Hb >and= 8.0g/dl Platelet >and= 80,000/mm3 Serum Creatinine <and= 1.5x upper limit of normal Total Bilirubin <and=2x upper limit of normal AST, ALT <and = 2x upper limit of normal 7) Patients must be more 20 year-old. 8) Patients must be expected to survive more than 3 months. 9) Written informed consent must be obtained from patients.
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) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 5) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of immune responses by measurement of cytotoxic T lymphocytes (CTL)and anti-peptide IgG) before and after peptide vaccination with metformin. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of long-term prognosis (progression free survival and overall survival). 2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University School of Medicine Research Center for Innovative Cancer Therapy, Division of Cancer Vaccine
Outcome results
None listed