malignant tumor
Conditions
Interventions
Peptides (maximum 4) among 27 (for HLA-A2, -A24, -A26, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant.
Sponsors
Kurume University Cancer Vaccine Center
Sendi public welfare hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients must be pathologically diagnosed as cancer, however, it is not necessary to possess target lesions for response evaluation. 2)Patients must be at a score level of 0-2 of performance status (PS) (ECOG). Exceptionally, PS3 patients only in neurological symptom can be enrolled. 3)Patients must have significant level of plasma IgG reactive to at least two of the vaccine candidate peptides. 4) Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings: WBC more than 2,500/mm3 Lymphocytes more than 1,000/mm3 Hb more than 8.0g/dl Platelet more than 80,000/mm3 Serum Creatinine less than 2x normal upper limit Total Bilirubin less than 2x normal upper limit 6)Patients must be more than 20 year-old. 7)Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A26, -A31, or -A33.
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 etc). 2) Patients with the past history of severe allergic reactions. 3) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation. 4) Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the peptide specific antibody before and after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Analyze the correlation between enhancemt of peptide specific antibody and all over survival. Adverse events of peptide vaccination are evaluated based on the CTCAE v3.0 (JCOG). | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division
Outcome results
None listed