PHASE IB TRIAL OF THE EFFECT OF PERITUMORAL AND INTRANODAL INJECTIONSOF INTERLEUKIN-2 IN PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OFTHE HEAD AND NECK - AN EASTERN-COOPERATIVE-ONCOLOGY-GROUP TRIAL

Thirty-six patients with unresectable squamous cell carcinoma of the h ead and neck were entered into a phase Ib trial evaluating the toxicit y, maximally tolerated dose (MTD), and immunomodulating effects of loc ally administered interleukin-2 (IL-2). Patients received daily IL-2 i njected perilesionally in divided doses in each of four quadrants and bilaterally into the superior jugular lymph nodes. The dose of IL-2 be gan at 200 U/day and was escalated to 4 x 10(6) U/day in groups of six patients. Overall, regionally administered IL-2 was well tolerated. T he most frequently encountered toxicities were fever, hepatotoxicity, and hypotension. Dose-limiting toxicity was encountered at 4 x 10(6) U . Of the 36 patients treated, 2 partial responses were noted at 2,000 and 4 x 10(6) U. We conclude that regionally administered IL-2 is well tolerated in patients with head and neck cancer and that the MTD is 2 x 10(6) U/day, similar to what has been reported with systemically ad ministered IL-2. Although the overall response rate was low, it may be improved with prolonged administration of IL-2 or by combining it wit h other biologic or cytotoxic agents.