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Herein we describe the first clinical treatment of renal cell carcinoma in humans with xenogeneic immune ribonucleic acid. Twelve patients with advanced renal cell carcinoma have been treated by appropriate operations to remove tumor bulk followed by specific passive immunotherapy. Xenogeneic specific immune ribonucleic acid was prepared from the spleen of normal sheep that had received 4 weekly injections of a homogenate of renal cell carcinoma. Results indicate that 1) xenogeneic specific immune ribonucleic acid can safely be given to humans without local or systemic toxicity, 2) there is a suggestion of clinical benefit, since only 2 patients have had progression of known metastases during treatment with immune ribonucleic acid and 3) xenogeneic immune ribonucleic acid can enhance the immune response to renal cell carcinoma, as demonstrated by in vitro lymphocytoxicity tests.

With a microcytotoxicity assay it was shown that normal, non-immune human lymphocytes were converted to effector cells specifically cytotoxic to human renal carcinoma cells after incubation with xenogeneic immune ribonucleic acids. The ribonucleic acid was extracted from the lymphoid tissues of sheep that had been immunized with human renal carcinoma tissue. Lymphocytes incubated without ribonucleic acid from or with ribonucleic acid sheep immunized with Freund's adjuvant alone did not increase cytotoxicity. Immunotherapy with immune ribonucleic acid increased cytotoxic activity of lymphocytes from a patient with metastatic renal carcinoma. The microcytotoxicity assay may be a useful method to assessing the cellular immune response in patients receiving immunotherapy and seems to correlate with their clinical course.

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