A multiple-dose phase I trial of recombinant leukocyte A interferon in cancer patients

Abstract

Eighty-one patients with a variety of refractory disseminated malignant neoplasms were treated in the 1st multiple fixed-dose phase I trial of recombinant leukocyte A interferon (IFL-rA). Each patient received IFL-rA by i.m. injection, 3 times/wk for 28 days. Dosages were escalated in different patients from 1 to 136 .times. 106 U/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 1st genetically engineered biological response modifier available for testing in cancer patients, is biologically active in vivo.