A multiple-dose phase I trial of recombinant leukocyte A interferon in cancer patients.
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 x 10(6) 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.
D000855:Anorexia / Q000209:etiology; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005221:Fatigue / Q000209:etiology; D005334:Fever / Q000209:etiology; D006801:Humans; D007273:Injections, Intramuscular; D007370:Interferon Type I / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D007700:Kinetics; D007970:Leukopenia / Q000209:etiology; D009369:Neoplasms / Q000628:therapy*; D013921:Thrombocytopenia / Q000209:etiology
D004274:DNA, Recombinant; D007370:Interferon Type I