colon cancer
Conditions
Interventions
(1st treatment: total 6 times, every weeks) Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these
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 diagnosed as colon cancer of standard therapy failed.Presence of target lesion is not considered. 2) Patients must be at a score level 0~1 of performance status (PS) (ECOG). 3) Patients must have IgG reactive to at least two of candidate peptides. 4)Patients must be expected to survive more than 3 months. 6) Patients must satisfy the followings: WBC is more than 2,500/mm3 Lymphocyte is more than 900/mm3 Hb is more than 8.0g/dl Platelet is more than 50,000/mm3 Serum Creatinine is less than 2.0mg/dl Total Bilirubin is less than 2.5mg/dl 6) Patients must be more 18year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.
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) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility. (Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination." 4) Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Analyze the correlation between enhancement of peptide specific antibody and all over survival. 2. Adverse effects and safety of peptide vaccination is evaluated based on the NCI-CTC. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Outcome results
None listed