PHASE-II TRIAL OF SEQUENTIAL RADIATION AND INTERLEUKIN-2 IN THE TREATMENT OF PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA

We have previously demonstrated that local tumor irradiation effective ly enhanced the therapeutic effect of interleukin 2 (IL-2) therapy in an experimental murine renal adenocarcinoma model. Based on these prec linical studies, we have designed and initiated a Phase II trial of ir radiation combined with IL-2 for the treatment of metastatic renal cel l carcinoma, Patients received 800 cGy to the primary or metastatic le sion on days 1 and 15 followed by IL-2 (600,000 IU/kg i,v,) every 8 h on days 4-8 and 18-22. Sixteen patients were entered; all completed tr eatment and are therefore evaluable for toxicity and response, Two par tial remissions were seen for a response rate of 12.5% (95% confidence interval, 0-28.7), There was no increase in toxicity over that which is anticipated from IL-2 alone, The antitumor activity seen in this tr ial is consistent with what would be expected from high-dose IL-2 alon e.