Abstract

2550 Background: Interferon alpha 1 (IFN α-1) has been suggested from prior clinical data to be potentially better tolerated than IFN α-2. The objectives of this trial were to confirm the safety, tolerability and maximum dose of recombinant human IFN α-1b and to measure the effects of IFN α-1b on known IFN induced gene products. Methods: Recombinant human IFN α-1b purified to homogeneity (specific activity 1.0 * 108 units/mg on MDBK cells) was obtained from the Ministry of Public Health in Shanghai. Eligible patients had histologically confirmed metastatic malignancy refractory to standard treatments. Patients were sequentially enrolled to receive increasing doses of IFN α-1b administered by SQ injection daily. Patients were monitored weekly and side effects were graded by the NCI common toxicity criteria. Biologic effects of IFN α-1b were assessed by measuring products of the IFN stimulated genes β2-microglobulin, GTP-cyclohydrolase, ISG 15 and TRAIL at baseline and on days 2, 8 and 29. Seven patients en...

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