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
Description: On days 14, 35, 56, 77 and 98 the appropriate dose of irradiated M20/A2B cells will be injected into three adjacent sites on the upper arm or thigh, avoiding limbs where lymph node dissection had been previously performed.Type: BiologicalA2/4-1BBL melanoma vaccine
Name: DNP sensititzation
Description: Include brand names, serial numbers and code names, if applicable. Other names are used to improve search results on the ClinicalTrials.gov web site. On days 1 and 2 patients will be sensitized to DNP by topically applying 0.1 ml of 2% DNP dissolved in acetone-corn oil (Sigma) to the inner aspect of the arm.Type: ProcedureA2/4-1BBL melanoma vaccine
Name: Cyclophosphamide
Description: On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.Type: DrugA2/4-1BBL melanoma vaccine
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 6Single 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 ---