Phase 1 Trial of Allogeneic Gene-Modified Tumor Cell Vaccine RCC-26/CD80/IL-2 in Patients with Metastatic Renal Cell Carcinoma

Results are reported from a safety trial in patients with metastatic Renal Cell Carcinoma (mRCC). An allogeneic, IL-2 secreting tumor cell line expressing the costimulatory molecule CD80 was injected following irradiation. Nine out of 15 subjects received the three sequential, increasing cell doses which were tolerated well. Delayed-type hypersensitivity skin reactions were noted. No tumor regression was observed but time to progression and survival improved. Elevated levels of effector cells toward multiple tumor associated antigens were detected.