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The clinical use of IL 2 and anthracycline in MRCC is based on pre-clinical studies that have shown a synergistic antitumor activity, due to an increased specific antitumor immunity (Gautam, Cancer Res. 1991; 51:6133–7). Seventeen pts (6 females and 11 males) with MRCC have been treated in a multicenter phase II study to test the safety and efficacy of low dose subcutaneous IL 2 in combination with EPI. The cycle consisted of IL 2 at 9 million I.U. for the first two days of the first week followed by 4.5 million I. U. for the remaining three days of the first week and for five days/week for five weeks, plus EPI at 25mg/mq the first day of each week. Median age was 56 years (46–71); median Karnofsky index was 90. Thirteen pts had prior nephrectomy. Three of these had syncronous metastases and were subjected to debulking surgery. Only two pts received prior chemotherapy or immunotherapy. The disease sites were: lung in 9 pts, lymph nodes in 7, kidney in 2, adrenal glands in 2, bone in 3 and renal bed in 2 pts. Fourteen pts are evaluable for response and toxicity, 3 are early to evaluate. We observed one CR and one PR lasting 14+ and 6 months, respectively. In the 8 pts with SD (57%) the median time to progression was 9 months (range 4+ to 12+). CR was obtained after two cycles in superficial lymph nodes and bone lesions while PR was noted in the lung. The toxicity was mild: only one pt had grade 3 hypotension; the most frequent toxicities (grade 1–2) were fever (9 pts) and malaise (5 pts). No pts required a decrease in IL 2 or EPI dosage. This study is ongoing and a larger number of patients are necessary to draw definitive conclusions concerning the efficacy of this chemo-immunotherapy combination in MRCC.