This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.
Name: A2/4-1BBL melanoma vaccine
Name: DNP sensititzation
Name: Cyclophosphamide
Description: Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response.
Measure: monitoring anti-tumor immune response Time: Day 0Description: Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response
Measure: monitoring anti-tumor immune response Time: Day 28Description: Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response
Measure: monitoring anti-tumor immune response Time: Day 56Description: Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response
Measure: monitoring anti-tumor immune response Time: month 3Description: Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response
Measure: monitoring anti-tumor immune response Time: month 4Description: Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response
Measure: monitoring anti-tumor immune response Time: month 5Description: Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response
Measure: monitoring anti-tumor immune response Time: month 6Allocation: N/A
Single Group Assignment
There is one SNP
5. Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor. --- V600E ---