Advanced cancer patients who are refractory to standard therapies for cancer
Conditions
Sponsors
Department of Immunology, Kurume University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be pathologically diagnosed as cancer, and are refractory to standard therapies for cancer. 2) Patients must possess target lesions for response evaluation. 3) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A31, or -A33. 4) Patients must have significant level of plasma IgG reactive to at least one of the vaccine candidate peptides. 5) When patients had received pre- therapies, including chemotherapy, immunotherapy, and radiation therapy, the vaccine therapy must be started more than 4 weeks after the last treatment. In case of 5FU and -related compounds, the vaccine therapy can be started more than 2 weeks of washout period. Patients must be not carried out anti-tumor effects or adverse effects of pre-therapy. 6) Patients must be at a score level of 0-2 of performance status (PS) (ECOG). 7) Patients must be expected to survive more than 3 months. 8) Patients must satisfy the followings: WBC more than 3,000/mm3 Lymphocytes more than 1,000/mm3 Hb more than 9.0g/dl Platelet more than 100,000/mm3 Serum Creatinine less than 1.4 mg/dl Total Bilirubin less than 1.5 mg/dl 9) Patients must be negative for Hepatitis virus B/C. 10) Patients must be more 20 year-old and less 80 year-old. 11) Written informed consent must be obtained from patients.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients are negative for HLA-A2, -A3, -A11, -A24, -A31, and -A33. 2) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc). 3) Patients with the past history of severe allergic reactions. 4) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation. 5) Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version). | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after vaccination. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division
Outcome results
None listed