Metastatic cancer resistant to standard treatments
Conditions
Interventions
Personalized peptide vaccination: One peptide is selected from 2 peptides restricted by HL-class II and 2 to 4 peptides are selected from 29 peptides restricted by HLA-class I based on higher peptid
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 malignant tumor. 2) Patients have metastatic disease. 3) Patients are resistant to standard treatments. 4) Patients must be positive for HLA-class I A (-A2, -A3, -A11,-A24, -A26,-A31 or -A33). 5) Patients must have IgG reactive to at least 1 peptide from 2 peptides restricted by HL-class II and 2 peptides from 29 peptides restricted by HLA-class I. 6) Patients must have at least 3 circulating tumor cells (CTC) measured by Cell Search. 7) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 8) Written informed consent must be obtained from patients. 9) Patients must be more 20 year-old. 10) Patients must be expected to survive more than 3 months. 11) Patients must satisfy the followings: WBC >and= 3,000/mm3 Lymphocyte >and=1,000/mm3 Hb >and= 8.0g/dl Platelet >and= 80,000/mm3 Serum Creatinine <and= 2.5x upper limit of normal Total Bilirubin <and=2x upper limit of normal
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients who had received pre-therapies including radiotherapy, chemotherapy or immunotherapy within 28 days before the treatment. 2) Patients who had received radiotherapy to the primary cancer lesion except for metastatic lesions within 2 weeks before the treatment. 3) Immunosuppressive treatment using a systematic steroid within the last 12 weeks was not permitted except for using low-dose steroid (less than 20mg as prednisolone). 4) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 5) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 6) Patients with the past history of severe allergic reactions. 7) Patients who had enrolled in another trial within 6 months or who are treating in another trial. 8) Patients who had received any peptides using this study. 9) Patients who are difficult to participate in this trial because of psychiatric symptoms. 10) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (safety assessments) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peptide-specific immune responses in PBMCs 2. Assessment of circulating tumor cells (CTC) | — |
Countries
Japan
Contacts
Public ContactShigeru Yutani
Kurume University School of Medicine Cancer Vaccine Center
Outcome results
None listed