Castration-resistant prostate cancer
Conditions
Interventions
A: Mixed 20 peptides vaccine at a dose level of 6mg/0.15mL is subcutaneously injected once a week for 6 weeks.
B: Mixed 20 peptides vaccine at a dose level of 20mg/0.5mL is subcutaneously injected o
Sponsors
Research Center for Innovative Cancer Therapy, Kurume University School of Medicine
1. Kyushu University Faculty of Medical Science, Fukuoka, Japan 2. Kitasato University School of Medicine, Kitasato, Japan 3. Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan
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. 2) Patients who had progressive disease after androgen deprivation therapy either by castration or with luteinizing hormone-releasing hormone (LHRH) agonists. 3) Patients who had progressive disease after anti-androgen therapy including bicalutamide or flutamide. 4) Anti-androgen therapy is discontinued for at least 4 weeks before the first vaccination for patients receiving flutamide and 6 weeks for those receiving bicalutamide. PSA progression is defined as at least 2 consecutive rises (>=25% from baseline) and level of >=5ng/mL in serum PSA taken over 2 weeks apart, in the setting of castration levels of testosterone. Radiological progressive disease is defined by CT, MRI or bone scan using RECIST criteria. 5) Patients have serum testosterone level >=50 ng/dL (0.5ng/mL) 6) Patients must be positive for HLA-A2, HLA-A24, HLA-A26 or HLA-A3 super type (A3,A11,A31,A33). 7) Written informed consent must be obtained from patients. 8) Patients must be more 20 year-old and less than 80 year-old. 9) Patients must be at a score level of 0-1 of performance status (ECOG). 10) Patients must be expected to survive more than 12 weeks. 11) Patients must satisfy the followings: WBC > 3,000/mm3 Lymphocyte > 1,000/mm3 Hb > 8.0g/dl Platelet > 80,000/mm3 Serum Creatinine <= 2.5 x upper limit of normal Total Bilirubin <= 2 x upper limit of normal
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients who had received pre-therapies including radiotherapy, chemotherapy or immunotherapy within 28 days before the treatment. 2) Patients who had received radiotherapy to prostate within the last 1 year before the treatment. 3) Immunosuppressive treatment using a systematic steroid within the last 1 year was not permitted except for using low-dose steroid. 4)Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 5) Patients with active multiple cancers. 6) Patients with the past history of severe allergic reactions. 7)Patients who do not agree with contraception during treatment and until 70 days after treatment. 8) Patients who had enrolled in another trial within 6 months or who are treating in another trial. 9) Patients who had received any peptides consist of a mixed 20 peptides (KRM-20). 10)Patients who are difficult to participate in this trial because of psychiatric symptoms. 11)Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects of a mixed 20 peptides vaccine / The safety of the protocol is evaluated based on the CTCAEv4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of immunological responses (cytotoxic T lymphocytes [CTL]and anti-peptide IgG) and minimum immunological effective dose. 2.PSA (prostate-specific antigen) response. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University School of Medicine Cancer Vaccine Division of Research Center for Innovative Cancer Therapy
Outcome results
None listed