A phase I trial of recombinant human gamma interferon (IFN-γ4A) in patients with advanced malignancy

Ruben Perez, Allan Lipton, Harold A. Harvey, Mary A. Simmonds, Paula J. Romano, Sharon L. Imboden, Gina Giudice, Michael R. Downing, N. K. Alton

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Abstract

We report a Phase I study in 39 cancer patients of the tolerance and biologic activity of 47 intravenous (i.v.), intramuscular (i.m.), and subcutaneous (s.c.) treatments with recombinant methional gamma interferon (IFN-γ4A) which most closely resembles the natural material produced by T lymphocytes. Patients were treated with IFN-γ4A 5 days a week for 2 weeks. After a 2-week rest period, patients were placed on the same dose of drug three times a week. The most common side effects—fever, chills, malaise, myalgias, and nausea and vomiting—were seen with all routes of administration. Reversible increases in hepatic transaminase and decrease in granulocytes counts were seen. The dose-limiting toxicities observed were malaise and orthostatic hypotension. The maximum tolerated dose was 500–1,000 μg/M2/day. The t1/2 of IFN-γ4A in the circulation was 20 min after i.v. injection. No blood levels were detected after i.m. or s.c. injection. Antibody against IFN-γ4A increased in three patients. A complete response was observed in one patient with pulmonary metastases from renal cell carcinoma.

Original languageEnglish (US)
Pages (from-to)309-317
Number of pages9
JournalJournal of Biological Response Modifiers
Volume7
Issue number3
StatePublished - Jun 1988

All Science Journal Classification (ASJC) codes

  • Immunology
  • Pharmacology
  • Cancer Research

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    Perez, R., Lipton, A., Harvey, H. A., Simmonds, M. A., Romano, P. J., Imboden, S. L., Giudice, G., Downing, M. R., & Alton, N. K. (1988). A phase I trial of recombinant human gamma interferon (IFN-γ4A) in patients with advanced malignancy. Journal of Biological Response Modifiers, 7(3), 309-317.