title: 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.
abstract: 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.
authors.affiliation: Department of Medicine, Pittsburgh Cancer Institute, University of Pittsburgh School of Medicine, Pennsylvania.
authors.forename: D R
authors.initials: DR
authors.lastname: Vlock
authors.forename: C H
authors.initials: CH
authors.lastname: Snyderman
authors.forename: J T
authors.initials: JT
authors.lastname: Johnson
authors.forename: E N
authors.initials: EN
authors.lastname: Myers
authors.forename: D E
authors.initials: DE
authors.lastname: Eibling
authors.forename: J S
authors.initials: JS
authors.lastname: Rubin
authors.forename: J M
authors.initials: JM
authors.lastname: Kirkwood
authors.forename: J P
authors.initials: JP
authors.lastname: Dutcher
authors.forename: G L
authors.initials: GL
authors.lastname: Adams
mesh_terms: 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
chemical_list: D007376:Interleukin-2