Prostate cancer
Conditions
Interventions
3.0mg of WT1 peptide and 0.1ml of pertussis whole cell vaccine will be administrated intradermally. The administration interval is essentially every week.
Sponsors
Department of Immunology, Kochi University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Treatment-failure prostate cancer patients who have been histologically diagnosed as prostate adenocarcinoma. Cases are divided into the following two categories. a) Hormone-refractory prostate cancer patients who have not already received any chemotherapy yet. b) Hormone-refractory prostate cancer patients who have already received one or more chemotherapies. 2) Patients must bear at lease one copy of either HLA-A*2402, -A*0201, or -A*0206 gene. 3) The tumor tissue is positibe by stained for WT1 by immunohistochemistry. 4) The patients' Karnofsky Index should be 60% or more(performance status(ECOG should be 0-2). 5) Expected survival time should be three months or greater. 6) Sufficient function of important organs including heart, lung, liver, kidney and bome marrow. And patients must satisfy the followings: Creatinin <= 3.0mg/dl BUN <= 25 mg/dl Total Bilirubin <= 1.5 mg/dl AST <= 105 U/l ALT <= 120 U/l Neutrophil >= 1,500/mm3 Platelet >= 75,000/mm3 Hemoglobin >= 8.0g/dl ECG: no serious object SpO2 >= 94% (room air) 7) Patients without additional malignant diseases 8) Written informed consents are obtained from patients after giving sufficient explanations and obtaining their understandings about disease conditions.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients with uncontrollable infectious disease (including active Tuberculosis). 2) Patients with severe symptoms (malignant hypertension, severe congestive heart failure, severe colonary insufficiency, Myocardial Infarction within three months lately, terminal phase liver cirrhosis, uncontrollable Diabetes Mellitus, severe Pulmonary Fibrosis, active interstitial pneumonia, etc.). 3) Patients previously treated with Allogeneic bone marrow transplantation. 4) Patients with severe psychiatric disease. 5) Patients who participate in any other clinical trial. 6) Patients who previously participated in this clinical trial. 7) Any patients disqualified by a study physician because of medical, psychological, or any other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of side effects (phase I) Progression-free survival (phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses | — |
Countries
Japan
Outcome results
None listed