Castration-resistant prostate cancer
Conditions
Interventions
1st treatment (total 8 times, every weeks): 4 peptide vaccines are selected from 31 peptide candidates restricted by HLA-class I, to which peptide-specific IgGs are detected before vaccination, and a
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 must be at a score level of 0-1 of performance status (PS) (ECOG). 3) Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type. 4) Patients must have IgG reactive to at least two of peptide candidates. 5) Patients must satisfy the followings: WBC > and = 2,500/mm3 Lymphocyte 500- 1,000/mm3 Hb > and = 8.0g/dl Platelet > and = 50,000/mm3 Serum Creatinine < and = 2.5x upper limit of normal Total Bilirubin < and = 2x upper limit of normal 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.
Exclusion criteria
Exclusion criteria: he 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 are judged inappropriate for the 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. | — |
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. 3. Evaluation of mild bone marrow suppression, as well as immune responses enhancing effects of functional food nutrition. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University School of Medicine Research Center for Innovative Cancer Therapy, Cancer Vaccine Division
Outcome results
None listed