Phase Ib trial of the effect of peritumoral and intranodal injections of interleukin-2 in patients with advanced squamous cell carcinoma of the head and neck: an Eastern Cooperative Oncology Group trial.
Thirty-six patients with unresectable squamous cell carcinoma of the head and neck were entered into a phase Ib trial evaluating the toxicity, maximally tolerated dose (MTD), and immunomodulating effects of locally administered interleukin-2 (IL-2). Patients received daily IL-2 injected perilesionally in divided doses in each of four quadrants and bilaterally into the superior jugular lymph nodes. The dose of IL-2 began 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. The 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 administered IL-2. Although the overall response rate was low, it may be improved with prolonged administration of IL-2 or by combining it with other biologic or cytotoxic agents.
Vlock
D R
DR
Department of Medicine, Pittsburgh Cancer Institute, University of Pittsburgh School of Medicine, Pennsylvania.
Snyderman
C H
CH
Johnson
J T
JT
Myers
E N
EN
Eibling
D E
DE
Rubin
J S
JS
Kirkwood
J M
JM
Dutcher
J P
JP
Adams
G L
GL
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D015552:Injections, Intralesional; D007272:Injections, Intralymphatic; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000627:therapeutic use / Q000633:toxicity*; D008297:Male; D008875:Middle Aged
D007376:Interleukin-2