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Recombinant Leukocyte A Interferon: Pharmacokinetics, Single-Dose Tolerance, and Biologic Effects in Cancer Patients

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.; and ZOFIA DZIEWANOWSKI, M.D., Ph.D.
[+] Article and Author Information

Grant support: grant CA 05831, National Cancer Institute; and support from Hoffman-La Roche, Inc. Research conducted in part by the Clayton Foundation for Research. Dr. Gutterman is a senior Clayton Foundation investigator.

▸Requests for reprints should be addressed to Jordan U. Gutterman, M.D.; Department of Clinical Immunology and Biological Therapy, The University of Texas M.D. Anderson Hospital and Tumor Institute; 6723 Bertner Ave.; Houston, TX 77030.


Houston, Texas; Nutley, New Jersey; and Stanford, California


©1982 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1982;96(5):549-556. doi:10.7326/0003-4819-96-5-549
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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.

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