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. 1987 Jul;25(1):54–58. doi: 10.1007/BF00199301

A phase I study of recombinant interferon gamma administered by s.c. injection three times per week in patients with solid tumours

John Wagstaff 1,✉, David Smith 2, Philipp Nelmes 3, Peter Loynds 3, Derek Crowther 2
PMCID: PMC11038087  PMID: 3109738

Abstract

Human recombinant DNA interferon gamma (IFN-G), with a specific activity of 2×106 IU/mg protein, was administered s.c. 3 days per week for 2 months to patients with solid tumors. The maximum tolerated dose (MTD) was 10×106 IU/m2 (5.0 mg/m2) per injection, and six patients were treated at the MTD. Two of these ceased treatment because of severe subjective toxity (headache, rigors and pyrexia) and three patients developed WHO grade 3 leucopenia. Subjective toxicity varied considerably between patients and some patients at low dose levels experienced severe constitutional symptoms whilst others treated at the MTD had few side effects. These differences were unrelated to pharmacokinetic parameters. Bioavailability of this IFN-G administered s.c. was very variable from one patient to another at the same dose level. We therefore counsel caution in using this IFN-G preparation s.c. in phase II studies.

Keywords: Cancer Research, Interferon, Solid Tumor, Dose Level, Pharmacokinetic Parameter

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