Interleukin-1 (IL-1) is a biological response modifier that has important roles as mediator in inflammation and in hematopoiesis. Although the ultimate role of IL-1 in cancer therapy may be as a hematopoietic stimulating factor, it has direct antitumor effects that might potentially be exploitable in patients. In this first study of IL-1 beta at the Biological Response Modifiers Program, we are increasing doses of IL-1 beta by half-log increments from a starting dose of .01 mog/kg given as a daily 15-minute infusion for 7 consecutive days. As of this date, we have escalated the dose to as high as .1 mog/kg. The toxic effects observed so far have been fever, chills, nausea, vomiting, and headache. There has been moderate hypotension that required pressors in one patient. One patient developed an acute hypertensive episode following her third dose of IL-1 that resulted in acute congestive heart failure with pulmonary edema. As of this date, three more patients are being accrued to this dose level to attempt to determine the frequency of this side effect. White blood cell increases up to 20,000 have been observed following IL-1 beta administration. These counts increase is entirely accounted for by increases in mature granulocytes and bands. More patients will be entered on this study to further characterize the toxic, hemopoietic, and immunomodulatory effects of IL-1 beta.
