Interferon-β in patients with low-grade astrocytomas — A phase I study

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Abstract
In 3 patients with low-grade astrocytomas clinical pharmacology of interferon-β (107 U/mg protein) was investigated. Interferon-β with escalating dosage (2.3, 6.9, 23, 69 X 106 U/patient) was given to each patient in 4 infusions at weekly time intervals. In these patients dose-dependant plasma-levels of interferon-β of up to 5800 IU/ml were achieved. Plasma concentrations showed a biphasic decline (T 1/2 1 : 0.095-0.49hrs and T 12 2 : 5–14.5hrs). Side effects were: mild fatigue, myalgia, tachycardia, hypertension, and fever; the latter was well controlled by pretreatment application of paracetamol. Hematological changes included lymphopenia (2–6 hrs after infusion) and granulocytosis (3–6 hrs after infusion). Natural Killer cell activity was also monitored: 6 hours after infusion a drop of activity — not clearly dose dependant — was observed to a minimum of 1% pretreatment activity; 24 hrs after infusion activity increased up to a maximum of 400%. In this phase I study high biological activity of interferon-β could be detected in plasma of astrocytoma patients — clinical tolerance was good and only mild toxicity was observed.