title: [Phase I-II study of recombinant interleukin-2].
abstract: A phase I-II study of recombinant interleukin 2 (rIL-2) (Shionogi Pharmaceutical Co.) was conducted against carcinoma of the lung (20 cases) and stomach (1 case) as well as metastatic pulmonary tumor (17 cases). The cytotoxicity of lymphocytes against K562, PC-9, PC-14 and Daudi cells was examined before and 1, 2, 3, 5, 7, 14, 21 and 28 days after rIL-2 administration. The subsets of lymphocytes and pharmacokinetics of rIL-2 were also analyzed. Four administration methods were used. 2-h drip infusion of 6.7 X 10(5) U/m2/day (A1: 6 cases) or 2.2 X 10(6) U/m2/day (A2: 8 cases) for 5 consecutive days, subcutaneous injection of 6.7 X 10(5) U/m2/day (B: 3 cases) for 28 consecutive days, 4-h continuous drip infusion of 3.3 X 10(5) U/m2/day (C1: B cases), 6.7 X 10(5) U/m2/day (C2: 7 cases) or 1.1 X 10(6) U/m2/day (C3: 5 cases) for 28 consecutive days, and (D) 24-h continuous drip infusion of 6.7 X 10(5) U/m2/day (D: 6 cases) for 5 consecutive days every week, repeating four cycles of the course. We discussed whether or not the problems of the phase I study with BRMs could be solved.
mesh_terms: D004334:Drug Administration Schedule; D004341:Drug Evaluation; D006801:Humans; D007116:Immunization, Passive; D007262:Infusions, Intravenous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D007694:Killer Cells, Natural / Q000276:immunology / Q000637:transplantation; D008175:Lung Neoplasms / Q000276:immunology / Q000556:secondary / Q000628:therapy*; D008214:Lymphocytes / Q000145:classification; D013274:Stomach Neoplasms / Q000276:immunology / Q000628:therapy*
chemical_list: D007376:Interleukin-2