A Phase I Study of Human Natural Interferon-β in Cancer Patients

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Abstract
In this phase I study 5 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 .times. 106 IU were administered every other day. The single maximal tolerated dose ranged from 9 to 46 .times. 106 IU. Eight patients tolerated the dose of 46 .times. 106 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.