Immunotherapy of Stage III/IV Melanoma Patients

Inclusion Criteria

• •1. Histologically confirmed stage III or stage IV melanoma with at least one metastatic lymph node and/or at least one in-transit metastasis. According to the AJCC rules, this includes all patients with stage IV and stage III. Patients with or without measurable disease may be included.
• •2. Tumor expression of Melan-A by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis for patients of group I.
• •Tumor expression of Melan-A and at least one of the tumor antigens MAGE-A10, NY-ESO-1, or LAGE-1 by rt-PCR analysis for patients of group II and III and for HLA-A2+ patients of groups IV and V. HLA-A2 negative patients of groups IV and V must only have NY-ESO-1 positive tumors to be eligible, while expression of Melan-A and MAGE-A10 is unimportant.
• •If no frozen tissue is available, immunohistochemistry may be performed to detect tumor expression of Melan-A and NY-ESO-1.
• •3. HLA-A2 positive (serological or molecular typing of Peripheral Blood Lymphocytes (PBL) for patients of groups 1 to 3. Patients of groups 4 and 5 may either be HLA-A2+ or HLA-A2-.
• •4. Expected survival of at least five months.
• •5. Full recovery from surgery.
• •6. Karnofsky scale performance status of 70% or more.
• •7. The following laboratory results:
• •Neutrophil count sup or equal 2.0 x 10\^9/L Lymphocyte count sup or equal 0.5 x 10\^9/L Platelet count sup or equal 100 x 10\^9/L Creatinine ≤ 2 mg/dL (180 micromol/L) Bilirubin ≤ 2mg/dL (34 micromol/L) Granulocyte count \> 2.5x10\^9/L AST \< 2x upper limit of normal aPTT: within the normal ranges of the laboratory ± 25 %
• •8. Age \> 18 years.
• •9. Able to give written informed consent.