A phase I study of human natural interferon-beta in cancer patients.
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.
Liberati
A M
AM
Clinica Medica I & R, Università di Perugia, Italy.
Biscottini
B
B
Fizzotti
M
M
Schippa
M
M
De Angelis
V
V
Senatore
M
M
Vittori
O
O
Teggia
L
L
Natali
R
R
Palmisano
L
L
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
D007370:Interferon Type I