Castration-resistant prostate cancer
Conditions
Interventions
A: Personalized peptide vaccination with oral herbal medicines treatment. Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides
Sponsors
Kurume University School of medicine, Department of Immunology and Immunotherapy
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, HLA-A26 or HLA-A3 super type. 4) Patients must have IgG reactive to at least two of peptide the candidate peptides restricted to the patient's HLA types. 5) If patients have used previously hochuekkito and/or keishibukuryougan, patients must wait a treatment for 4 weeks. 6) Patients must be expected to survive more than 3 months. 7) Patients must satisfy the followings: WBC >and= 2,500/mm3 Lymphocyte >and=1,000/mm3 Hb >and= 8.0g/dl Platelet >and= 100,000/mm3 Serum Creatinine <and= 2.5x upper limit of normal Total Bilirubin <and=2x upper limit of normal 8) Patients must be more 20 year-old. 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. 2) Patients with the past history of severe allergic reactions. 3) Patients who are judged inappropriate for the clinical trial by doctors. 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 |
|---|---|
| Comparison of immune-enhancing effects between two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of peptide-specific CTL responses in PBMCs between two groups. 2. Comparison of safety between two groups. 3. Comparison of overall survival between two groups . | — |
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