[A phase I study of recombinant interleukin 2 (S6820)].
Forty patients with refractory malignancies were treated with recombinant human interleukin 2 (IL2) in a cooperative phase I study. IL2 was administered intravenously in six groups of patients at doses of 1 x 10(4), 3.3 - 5 x 10(4), 1 x 10(5), 3.3-5 x 10(5), 1 x 10(6) and 3.3 x 10(6) U/day and subcutaneously in 4 patients at a dose of 1 x 10(6) U/day for 5 days, respectively. Toxicity was dose related and consisted of fever and chills (52.7%), gastrointestinal disturbance (19.4%), rash, arthralgia, eosinophilia and hepatotoxicities. All the patients recovered from these soon after the administration was completed. Hypotension was observed in 3 patients at a dose of 3.3 x 10(6) U/day and in one instance was so severe that withdrawal was necessary. Enhancement in NK and LAK cell activity was noted at doses of 1 x 10(6) U/day or higher. This investigation indicates that the optimal dose is 1 x 10(6) U/day and will aid in the design of a phase 2 study with IL2.
Takaku
F
F
D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007694:Killer Cells, Natural / Q000276:immunology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
D007376:Interleukin-2; D011994:Recombinant Proteins