Prostate cancer
Conditions
Interventions
A: Select peptide candidates (up to 4), to which CTL precursors or peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulat
Sponsors
Kurume University School of medicine, Department of Immunology
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-andorogen therapy, or female hormone therapy. The patients must be suffering from hormone refractory prostate cancer(#1,2,3,4) #1: The measurable tumor size must be more than 2 cm by X-ray and the level of PSA must increase more than 3 times consecutively at more than 2 weeks interval. #2: Patients must be drug-free more than 4 weeks after hormone therapies or chemotherapies. The hormone withdrawal syndrome must be ruled out. #3: In the cases of patients without castration, the LH-RH analogue therapy will be continued to keep the level of testosterone. #4: Patients must not receive the treatment with bisphosphonate and steroid. 2) Patients must be positive for HLA-A2 or HLA-A24. 3) Patients must have IgG reactive to at least one of peptide candidates. 4) When patients had received pre-therapies, including chemotherapy, immunotherapy, and radiation therapy, the vaccine therapy must be started at least more than 4 weeks after the last therapy. Patients showing anti-tumor effects or adverse effects of pre-therapy must be excluded. 5) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 6) Patients must be expected to survive more than 3 months. 7) Patients must satisfy the followings: WBC >= 3,000/mm3 (Lymphocyte >= 1,200/mm3) Hb >= 9.0 g/dl Platelet >= 100,000 /mm3 Serum Creatinine <= 1.4 mg/dl Total Bilirubin <= 1.5 mg/dl 8) Patients must be negative for Hepatitis virus B/C. 9) Patients must be more 20 year-old and less 80 year-old. 10) 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. Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. adverse events 2. overall survival 3. Subjective effects (pain due to metastatic lesion, symptoms based on urinary disturbance due to primary lesion, PS, progression of cancer / change of body weight according to improvement) and evaluation of quality of life based on FACT examination sheet. 4. Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University School of Medicine Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division
Outcome results
None listed