Active specific immunotherapy of stage IV renal carcinoma with aggregated tumor antigen adjuvant

Active-specific immunotherapy of human malignancy with a vaccine consisting of admixtures of modified tumor antigens and an adjuvant such as tuberculin has not been fully explored, despite preliminary reports of clinical success and conceptual support from animal studies. Three years ago, we designed a prospective study using aggregated soluble tumor antigens admixed with tuberculin or phytohemagglutinin as an adjuvant (TAA) in order to treat patients with Stage IV renal carcinoma. Autologous tumor vaccines were used initially in 24 patients with operatively accessible tumor, although most patients eventually were switched to allogeneic preparations. Scarifications with Bacillus-Calmette Guerin were used in order to ensure maximum reactivity to tuberculin and patients received no other therapy while in the study. Two patients achieved complete remission and 2, partial remission. The overall survival rate for the 30 patients entered is equivalent to reported survival rates for patients with extensive disease treated with aggressive surgery with or without chemotherapy. We believe these results offer strong preliminary evidence of efficacy of this particular type of therapy in an advanced human malignancy.