JORDAN U. GUTTERMAN, M.D.; SEYMOUR FINE, M.D.; JORGE QUESADA, M.D.; SANDRA J. HORNING, M.D.; JEDD F. LEVINE, M.D.; RAYMOND ALEXANIAN, M.D.; LEON BERNHARDT, M.D.; MICHAEL KRAMER, Ph.D.; HERBERT SPIEGEL, Ph.D.; WAYNE COLBURN, Ph.D.; PATRICK TROWN, Ph.D.; THOMAS MERIGAN, M.D.; ZOFIA DZIEWANOWSKI, M.D., Ph.D.
Sixteen patients with advanced cancer were treated with recombinant-DNA-produced pure leukocyte A interferon (IFLrA) intramuscularly in doses ranging from 3 to 198 X 106 units, with interval periods of 72 to 96 hours between doses. At the two lowest doses of 3 and 9 million units, there was a cross-over evaluation between IFLrA and partially pure leukocyte interferon (IFN-C) produced from human cells. The maximum observed serum concentration of IFLrA measured by enzyme immunoassay and bioassay increased with increasing doses. The mean serum concentrations of IFLrA and IFN-C were similar. Clinical effects produced by IFLrA and IFN-C were similar, including fever, chills, myalgias, headache, fatigue, and reversible leukopenia and granulocytopenia. Eight patients had transient and mild numbness of the hands or feet, or both. Three patients developed low titers of antibody to IFLrA. Seven of 16 patients showed objective evidence of tumor regression during the study.
GUTTERMAN JU, FINE S, QUESADA J, HORNING SJ, LEVINE JF, ALEXANIAN R, et al. Recombinant Leukocyte A Interferon: Pharmacokinetics, Single-Dose Tolerance, and Biologic Effects in Cancer Patients. Ann Intern Med. ;96:549–556. doi: 10.7326/0003-4819-96-5-549
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Published: Ann Intern Med. 1982;96(5):549-556.
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