Cancer, sarcoma Cancer, sarcoma
Conditions
Interventions
Cancer vaccination
Neo-antigen, cancer, antigen-presenting cell, vaccine
Sponsors
Shimodaira Shigetaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at the time of informed consent: 20 to 75 years old 2. Performance status: 0/1 3. Pathological diagnosis as a tyep of cancer or sarcoma 4. Adjuvant therapy during the course of standard therapies 5. Already determined neo-antigens (Genetic mutation) under the cancer genomic diagnosis 6. Neither cardiovascular diseases nor respiratory disorders that would prevent blood apheresis 7. No organ function abnormalities, no blood abnormalities, no bleeding tendency 8. No infectious diseases 9. Understand the risk and benefit of the dendritic cell-vaccination 10. No other clinical trials
Exclusion criteria
Exclusion criteria: 1. Application of molecular target medicine based on cancer genomic diagnosis 2. Allergy to penicillin or OK-432 3. Advanced diseases such as obstructive jaundice and involvement either in pleura or in peritoneum 4. Requiring platelet or red blood cell transfusion or albumin infusion 5. Disseminated intravascular coagulation syndrome and deep vein thrombosis 6. An infectious disease such as viral hepatitis (following the standard of the Japanese Red Cross Blood Center) 7. History of cerebrovascular disorders such as cerebral hemorrhage and infarction 8. Poor control of lung diseases such as chronic obstructive lung disease, bronchial asthma, and requiring oxygen dosage 9. Pneumonitis (the past) 10. Autoimmune diseases (present or the past) 11. Steroid hormone therapy continuously administered for diseases other than the prevention of temporal chemotherapeutic drug allergy 12. Mental disease (including neurosis, the panic disorder) 13. The past of epilepsy having poor control 14. Difficulty in arm vessel blood access for apheresis 15. No informed consent due to cancer 16. Inability to understand the risk and benefit of the DC vaccination 17. Pregnant or nursing women, desire to bear children 18. Under the treatment with immune checkpoint inhibitors during this clinical trial 19. Under the radiotherapy during this clinical trial 20. Physician judgment that a patient is inappropriate for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (adverse reactions, severe adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. One- and two-years survival ratio 2. Overall survival rate 3. Progression free survival at the 1 and 2 years 4. Antitumor effect (RECIST) 5. DTH (delayed type hypersensitivity reaction) 6. Immune monitoring of the biomarkers (ELISpot assays, T cell markers) 7. QOL 8. Biomarker Search | — |
Countries
Japan
Contacts
Public ContactKenichi Yoshida
Kanazawa Medical University hospital
Outcome results
None listed