Prostate cancer
Conditions
Interventions
<
Sponsors
Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1. Patients must be diagnosed as prostate cancer pathologically after the treatment of castration, LH-RH analogue therapy, anti-androgen therapy, or female hormone therapy. 2. Patients must be decetaxel no indicated. 3. Patients must be at a score level of 0-2 of performance status (PS) (ECOG). Patient with PS3 is acceptable if limited to neural symptoms. 4. Patients must be positive for HLA-A24. 5. Patients must have IgG reactive to at least two of peptide candidates. 6. Patients must be expected to survive more than 3 months. 7. Patients must satisfy the followings: WBC >3,000/mm3 Lymphocyte >900/mm3 Hb >8.0g/dL Platelet >75,000/mm3 Serum Creatinine >2.0 mg/dL Total Bilirubin >1.5 mg/dL 8. Patients must be more 20 years 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) Patients with multiple cancers 3) Patients with the past history of severe allergic reactions. 4) Patients who are not accept contraception during the 1st vaccination to 70 days after the last vaccination. 5) Patients with positive for hepatitis B or C virus. 6) Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival of peptide vaccination with BSC will be compared with that of BSC patients who are not enrolled this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival of peptide vaccination with BSC will be compared with that of BSC group. 2. 12 month survival rate of the 2 groups will be compared. 3. Anti-tumor effect (clinical responses) will be evaluated by RECIST criteria. 4. Adverse effects/safety will be evaluated by CTCAE v.3.0. 5. Evaluation of immunological effects (cytotoxic T lymphocytes (CTL), anti-peptide IgG) before and after peptide vaccination. | — |
Countries
Japan
Contacts
Public ContactMasanori Noguchi
Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
Outcome results
None listed