Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients

Inclusion Criteria: For both stage III and IV Histological proof of cutaneous melanoma Melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of cells by immunohistochemistry staining, HLA type A2 and/or A3, with known HLA-DR4 expression, 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. Expected adequacy of follow-up, Written informed consent. For Stage III only Stage III melanoma according to the 2001 AJCC criteria. Start of treatment within 2 months of lymph node dissection for melanoma stage III For stage IV only -Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x upper limit of normal Exclusion Criteria: For both stage III and IV No autoimmune disorders, no concomitant use of immunosuppressive drugs, no serious concomitant disease, no serious active infections, no other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin, No known allergy to shell fish (contains KLH) are excluded. No pregnancy or lactation, For stage III only: No signs or symptoms of distant metastases as defined by normal history, physical examination, chest X-ray and serum LDH. No concomitant or previous systemic treatment for melanoma For stage IV only: No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this. No prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.