PHASE-II STUDY OF LOW-DOSE CYCLOPHOSPHAMIDE AND INTRAVENOUS INTERLEUKIN-2 IN METASTATIC RENAL-CANCER

Thirteen patients with metastatic renal cancer were treated in a phase II trial with interleukin-2, 21.6 million IU/m(2) intravenously daily for five days on two consecutive weeks, starting 3 days after the adm inistration of low dose cyclophosphamide 350 mg/m(2) intravenously. Tr eatment cycles were repeated every 21 days. No responses were seen (95 % Confidence Interval. 0-22%). The most common toxicities were fever, fatigue, hypotension, nausea/emesis, and myalgia/arthralgia. There wer e 11 episodes of Grade III toxicity including Grade III hypotension in 7 patients. Because of the significant toxicity and the lack of obser ved response, the study was discontinued. Cyclophosphamide and interle ukin-2 at the dose and schedule used in this study has considerable to xicity and is unlikely to improve on response rates previously seen wi th other IL-2-based regimens in metastatic renal cancer.