title: A clinical phase I/II trial of rhIL-4 applied topically in patients with oral squamous cell carcinomas to assess safety and therapeutic activity.
abstract: Besides its immunoregulatory effects, interleukin-4 (IL-4) has growth inhibitory activity on cells from human solid tumors, and IL-4 receptors are present on tumor cells including cells from head and neck squamous cell carcinomas. We have conducted a phase I/II trial in patients with oral squamous cell carcinomas of T(4), N(+) (1 exception) stage to assess safety and therapeutic activity of recombinant human (rh) IL-4 applying the drug intratumorally 3 times a week with dose escalation for a duration of 4 weeks. A total of 7 patients entered the study using doses of 1, 3, and 5 microg/kg. There was no reduction of tumor size with 1 patient showing clear progression of the tumor after 4 weeks of treatment. This, and the observation of limiting toxicity occurring as local pain at the injection site, led to study termination. Therefore, rhIL-4 cannot be recommended as an antitumor drug in this disease using monotherapy with the schedules applied in this trial.
authors.affiliation: Department of Oral and Maxillofacial Surgery, Central German Armed Forces Hospital, Rübenacher Strasse 170, 56072 Koblenz, Germany.
authors.forename: Richard
authors.initials: R
authors.lastname: Werkmeister
authors.forename: Thomas
authors.initials: T
authors.lastname: Fillies
authors.forename: Christoph
authors.initials: C
authors.lastname: Gaertner
authors.forename: Ulrich
authors.initials: U
authors.lastname: Joos
authors.forename: Wolfgang E
authors.initials: WE
authors.lastname: Berdel
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D015847:Interleukin-4 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010146:Pain / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D015847:Interleukin-4