Recurrent solid cancers
Conditions
Interventions
Neoantigen-specific dendritic cell (DC) vaccines therapy (phase Ia) is going to be perform ed against recurrent solid cancers harboring accordant neoantigen mutation and HLA-typing.
Sponsors
Akiyama Yasuto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histological diagnosis of cancers 2.Cancer patients who are enrolled in HOPE project 3.Cancer patients who are subjected to clinical sequencing 4.Postoperative patients whose genetic profiling is accordant with neoantigen mutant peptides and HLA-typing list 5.Advanced(metastatic)or relapsed cancers after the standard therapy regimens Advanced (metastatic) cancer patients who rejected the standard therapy 6.Over 20 years old 7.Performance status 0-2 8.Measurable lesions by imaging diagnosis 9.No severe organ dysfunction 10.No severe hemostatic disorders 11.Expecting diagnosis with more than 3 months 12.Over 2week interval after the previous treatment 13.Informed consents obtained
Exclusion criteria
Exclusion criteria: 1.Within 14 days after the last cancer treatment 2.Severe systemic infection, hemostatic dysfunction and organ disorders 3.Systemic administration of steroids or immunosuppressant drugs 4.Pregnant women 5.Hypersensitivity to dendritic cell vaccines 6.Severe immunological disorders (autoimmune disease, immunosuppression) 7.Multiple cancers 8. Any of syphilis, hepatitis B, hepatitis C,HTLV-1 and HIV-1 infection is detected 9. Excluded patients according to the decision by medical doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of dendritic cell vaccines More than 4-time dendritic cell vaccines during 2 months after the onset of vaccination is rated as completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Immunological response (skin test, CTL as say) 2.Response rate 3.Relapse-free survival 4.Overall survival | — |
Countries
Japan
Contacts
Public ContactNaoko Sugisawa
Shizuoka Cancer Center
Outcome results
None listed