Vaccination of Melanoma Patients With Dendritic Cells Loaded With Allogeneic Apoptotic-Necrotic Melanoma Cells

Inclusion Criteria

• •histologically confirmed cutaneous melanoma stages IIB, IIC, III or IV (AJCC)
• •pts with minimal or non-detectable disease (NED) after surgery as asserted by CAT scans. Melanoma pts with unknown primary tumor site could be included in the study
• •life expectancy \> 6 months
• •ages:from 15 to 60 years
• •performance status (ECOG) 0 or 1
• •pts with stage III disease had to be previously treated with IFN-alpha, and either finished the treatment or suspended it due to disease progression, toxicity or other clinical reasons. Alternatively, those pts who had not started IFN-alpha within six months after surgery could be included in this study
• •a suitable venous access for the leukapheresis procedure
• •laboratory eligibility criteria included: hemoglobin \> 10 gr %; WBC count \> 4800/mm3, platelets \> 150.000/mm3, total and direct bilirubin, serum oxalacetic transaminase and glutamic pyruvic transaminase \< 1.5 fold the upper normal value; LDH \< 450 mU/ml
• •absence of pregnancy, with serum βHCG determined one week before vaccination in premenopausal women
• •serum creatinine \< 1.4 mg %
• •no chemotherapy, radiotherapy or any biological treatments during the previous month
• •no concurrent medication with corticosteroids or NSAIDs
• •l no active brain metastases m- normal ECG
• •all pts gave written informed consent before inclusion in the Study.