title: A phase I study of human natural interferon-beta in cancer patients.
abstract: In this phase I study 15 patients with metastatic tumors were given interferon (IFN)-beta by i.v. bolus injections. Twelve individual doses of 1, 2, 3.3, 5, 7, 9, 12, 16, 21, 27, 35, and 46 x 10(6) IU were administered every other day. The single maximal tolerated dose ranged from 9 to 46 x 10(6) IU. Eight patients tolerated the dose of 46 x 10(6) IU without side effects. Disturbances of cardiac rhythm were observed, but were closely related temporally to severe chills and appeared to be the consequence of adrenergic stimulation associated with this side-effect. In addition, no significant variations in the left ventricular function as assessed by nuclear stethoscope were observed. Neurotoxicity was not a major side-effect. The toxicity of IFN-beta given as scheduled in this study was significant, but acceptable.
authors.affiliation: Clinica Medica I & R, Università di Perugia, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Liberati
authors.forename: B
authors.initials: B
authors.lastname: Biscottini
authors.forename: M
authors.initials: M
authors.lastname: Fizzotti
authors.forename: M
authors.initials: M
authors.lastname: Schippa
authors.forename: V
authors.initials: V
authors.lastname: De Angelis
authors.forename: M
authors.initials: M
authors.lastname: Senatore
authors.forename: O
authors.initials: O
authors.lastname: Vittori
authors.forename: L
authors.initials: L
authors.lastname: Teggia
authors.forename: R
authors.initials: R
authors.lastname: Natali
authors.forename: L
authors.initials: L
authors.lastname: Palmisano
mesh_terms: D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000209:etiology; D001772:Blood Cell Count; D001794:Blood Pressure; D001831:Body Temperature; D004341:Drug Evaluation; D004569:Electroencephalography; D005334:Fever / Q000209:etiology; D006331:Heart Diseases / Q000209:etiology; D006339:Heart Rate; D006801:Humans; D007370:Interferon Type I / Q000494:pharmacology / Q000633:toxicity*; D007970:Leukopenia / Q000209:etiology; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000628:therapy*; D012129:Respiratory Function Tests
chemical_list: D007370:Interferon Type I