title: Systemic administration of recombinant methionyl human interleukin-2 (Ala 125) to cancer patients: clinical results.
abstract: Nineteen evaluable patients with advanced malignancy were treated with recombinant methionyl human interleukin-2 (Ala 125), 5 days per week by intravenous bolus. Patients were entered in five groups at starting doses ranging from 0.05 to 2.56 x 10(6) U/m2. Doses were escalated weekly as tolerated toward a potential maximal dose of 11.6 x 10(6) U/m2. Maximal tolerated dose was 3.84 x 10(6) U/m2. Dose-limiting toxicity included fatigue, rigors, nausea/vomiting, fever, and diarrhea. Other toxicities included hyperesthesias, arthralgias/myalgias, rash, fluid retention, balanitis, and mild confusion. Leukocytosis, including granulocytosis, eosinophilia, and mild lymphocytosis, was observed, as was rare mild thrombocytopenia. No partial or complete response occurred. T1/2 alpha averaged 13.4 min, with interleukin-2 detectable 2 h after doses of greater than or equal to 2.56 x 10(6) U/m2. Three patients developed anti-IL-2 antibodies without demonstrable clinical significance.
authors: Department of Medicine, UCLA School of Medicine.
authors: G P
authors: GP
authors: Sarna
authors: R A
authors: RA
authors: Figlin
authors: M
authors: M
authors: Pertcheck
authors: B
authors: B
authors: Altrock
authors: S A
authors: SA
authors: Kradjian
mesh_terms: D001835:Body Weight / Q000187:drug effects; D002118:Calcium / Q000097:blood; D004064:Digestive System / Q000187:drug effects; D006801:Humans; D007118:Immunoassay; D007275:Injections, Intravenous; D007376:Interleukin-2 / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007668:Kidney / Q000187:drug effects; D008099:Liver / Q000187:drug effects; D009369:Neoplasms / Q000401:mortality / Q000628:therapy*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D012137:Respiratory System / Q000187:drug effects; D012709:Serum Albumin / Q000378:metabolism
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins; D012709:Serum Albumin; D002118:Calcium