Immunization with Interleukin-2 Transfected Melanoma Cells. A Phase I–II Study in Patients with Metastatic Melanoma. University Hospital Leiden

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Abstract
The safety, tolerance and clinical effects of immunization with irradiated, allogeneic melanoma cells that express high levels of HLA-A1 and -A2 and secrete IL-2 after transfection with the Interleukin-2 gene, will be assessed in HLA-A1 or HLA-A2 positive melanoma patients with metastatic disease. As a pilot, the first 5-10 patients, if no immediate regression of tumor lesions are observed, will in addition to immunization with these allogeneic tumor cells receive recombinant IL-2 in relatively low doses during three consecutive weeks on an outpatient basis. If no clinical remissions are induced in these first 5-10 patients, subsequent 5-10 patients will receive the same dose of melanoma cells without additional rIL-2. Thereafter the dose of injected melanoma cells will be increased in every following 5-10 patients, but all subsequent patients will receive only IL-2 producing, allogeneic tumor cells, without the addition of rIL-2.