title: Phase I trial of continuous infusion recombinant interleukin-2 and intermittent recombinant interferon-alpha 2a: clinical effects.
abstract: A phase I trial of high-dose continuous infusion rIL-2 over 5 days and i.m. recombinant human interferon-alpha (rHuIFN-alpha 2a) three times weekly in 23 patients with advanced malignancy has been completed. Cohorts of patients were treated at three different dose levels: rIL-2 3.0 x 10(6) u/m2 plus rHuIFN-alpha 2a either 5.0 or 10.0 x 10(6) u/m2, and rIL-2 4.5 x 10(6) u/m2 plus rHuIFN-alpha 2a 5.0 x 10(6) u/m2 over 4 weeks. Dose-limiting toxicity consisted of pulmonary and neurologic side effects, and the maximal tolerated dose was 3.0 x 10(6) u/m2 on days 1-5 or rIL-2, and 10.0 x 10(6) u/m2 three times weekly of rHuIFN-alpha 2a. Four partial responses (renal carcinoma, three; endometrial carcinoma, one) were seen. In conclusion, toxicity of this schedule of rIL-2 and rHuIFN-alpha 2a was significant, but manageable. Further investigation is needed to define the antitumor activity of this combination.
authors.affiliation: Department of Hematology and Medical Oncology, Cleveland Clinic Foundation, Ohio 44195-5236.
authors.forename: R M
authors.initials: RM
authors.lastname: Bukowski
authors.forename: S
authors.initials: S
authors.lastname: Murthy
authors.forename: J
authors.initials: J
authors.lastname: Sergi
authors.forename: G T
authors.initials: GT
authors.lastname: Budd
authors.forename: S
authors.initials: S
authors.lastname: McKeever
authors.forename: S V
authors.initials: SV
authors.lastname: Medendorp
authors.forename: R
authors.initials: R
authors.lastname: Tubbs
authors.forename: V
authors.initials: V
authors.lastname: Gibson
authors.forename: J
authors.initials: J
authors.lastname: Finke
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000628:therapy; D004341:Drug Evaluation; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000633:toxicity; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000633:toxicity; D007680:Kidney Neoplasms / Q000628:therapy; D008168:Lung / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D009420:Nervous System / Q000187:drug effects; D011994:Recombinant Proteins; D014594:Uterine Neoplasms / Q000628:therapy
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins