Augmentation of Dendritic Cell Based Vaccines in Melanoma Patients by Depletion of Regulatory T Cells With an Anti-CD25 Monoclonal Antibody (Daclizumab). A Clinical Study.
1. Histologically documented evidence of melanoma.
2. Stage IV melanoma according to the 2001 AJCC criteria.  Limited tumor burden; LDH
< 2x upper limit of normal.
3. HLA-A2.1 phenotype according to lymphocyte HLA typing.
4. Expression of gp100 and/or tyrosinase on melanoma cells, as detected by
immunohistochemistry, preferably on metastatic tumor, but if not available on primary
5. ECOG performance status 0-1, life expectancy > 3 months.
6. Age 18-75 years. -
7. Written informed consent.
8. Expected adequacy of follow-up.
9. WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum
creatinine < 150 μmol/l, serum bilirubin < 25 μmol/l.
10. No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS
metastases CT scan of the brain should be performed to exclude this.
11. No prior chemotherapy, immunotherapy, or radiotherapy within three months before
planned vaccination is allowed.
12. No previous treatment with monoclonal antibodies.
13. No concomitant use of corticosteroids or other immunosuppressive agents.
14. No history of second malignancy within the last 5 years. Adequately treated basal
carcinoma of skin or carcinoma in situ of cervix is acceptable within this period.
15. No serious concomitant disease, no active infections. Specifically, patients with
autoimmune disease or organ allografts, and HBsAg or HIV positive patients are
16. Patients with a known allergy to shell fish (contains KLH) are excluded.
17. Patients with asthma or severe allergic disease necessitating medication are excluded
18. No pregnant or lactating women.