November 19, 1982

A Multiple-Dose Phase I Trial of Recombinant Leukocyte A Interferon in Cancer Patients

Author Affiliations

From the Biological Response Modifiers Program, Division of Cancer Treatment, National Cancer Institute, Frederick Cancer Research Facility, Frederick, Md (Drs Sherwin, Knost, Abrams, Foon, Ochs, Maluish, and Oldham and Ms Schoenberger); and Hoffmann-La Roche Inc, Nutley, NJ (Dr Fein).

JAMA. 1982;248(19):2461-2466. doi:10.1001/jama.1982.03330190025025

Eighty-one patients with a variety of refractory disseminated malignant neoplasms have been treated in the first multiple fixed-dose phase I trial of recombinant leukocyte A interferon (IFL-rA). Each patient received IFL-rA by intramuscular injection, three times weekly for 28 days. Dosages were escalated in different patients from 1 to 136×106 units per injection. The toxic reactions seen with IFL-rA resembled those of nonrecombinant leukocyte interferon and included fever, chills, fatigue, anorexia, myalgia, headache, occasional nausea and vomiting, and dose-dependent reversible leukopenia and hepatic transaminase elevations. The pharmacokinetics of IFL-rA were also comparable with nonrecombinant leukocyte interferon. Objective evidence of antitumor activity was seen in non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, breast cancer, and melanoma, indicating that IFL-rA, the first genetically engineered biological response modifier available for testing in cancer patients, is biologically active in vivo.

(JAMA 1982;248:2461-2466)