malignant tumor
Conditions
Interventions
For patients with HLA-A2, -A24, -A26, or -A3 supertype, HLA-matched vaccine peptides (maximum 4 peptides) with anti-peptide IgG in plasma are administered with Freund incomplete adjuvant. Each peptide
Sponsors
Kurume University Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients must be pathologically diagnosed as cancer. However,they do not need to possess target lesions for response evaluation. 2) Patients must be at the performance status(PS) score levels of 0 to 2 (ECOG). Exceptionally, PS3 patients only in neurological symptom can be enrolled. 3) Patients must have IgG reactive to at least two of HLA-matched candidate peptides in plasma. 4) Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings: WBC number is more than 2,500/mm3 Lymphocyte number is more than 1,000/mm3 Hb is more than 8.0g/dl Platelet number is more than 80,000/mm3. Exceptionally, platelet number is more than 50,000/mm3 in lirer cancer Serum creatinine is less than 2 times of upper limit of nomal. Total bilirubin is less than 2 times of upper limit of nomal. 6) Patients must be more than 20 years old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3supertype.
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 the past history of severe allergic reactions. 3) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use of effective contraception during and for at least 70 days after study participation. 4) Patients with the past history of cancer peptide vaccinations. 5) Patients with the past history of cancer peptide vaccinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of antigen-specific immune responses after 12 and 18 times of vaccinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse effects and safety of personalized peptide vaccination are evaluated based on the CTCAE Version 4.0 2. Overall survival | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Outcome results
None listed