metastatic melanoma
Conditions
Interventions
Administration of peptide cocktail and KLH-treated dendritic cell vaccines to malignant melanoma patients within the dose of 5x107
Sponsors
Shizuoka Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of malignant melanoma 2. Metastatic melanoma of clinical stage IV 3. 20<=Age<80 4. Performance status; 0-2 5. Measurable lesions in imaging diagnosis 6. HLA genotyping; HLA-A2 or A24 7. No severe organ dysfunction 8. Tolerable to apheresis procedure 9. No severe hematostatic dysfunction 10. Informed consents obtained from patients 11. Survival for more than 6 months expected 12. More than 4 weeks interval after last treatment against cancer
Exclusion criteria
Exclusion criteria: 1. Within 28 days after the last treatment against cancer 2. Severe systemic infection, hematostatic dysfunction, and organ disorder 3. Steroid treatment, except used for cerebral decompression 4. Pregnant women 5. Hypersensitivity to DC vaccine 6. Severe immunological disoedres (autoimmune disease, immunosuppression) 7. Multiple cancers 8. Anaphylaxis to synthetic peptides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antitumor effect and safety of DC-based immunotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological effect, effect on overall survival time | — |
Countries
Japan
Contacts
Public ContactYasuto Akiyama, M.D.
Shizuoka Cancer Center Research Institute Immunotherapy Division
Outcome results
None listed