Recombinant human interleukin-1 beta: new possibilities for the prophylaxis and correction of toxic myelodepression in patients with malignant tumors. I. Phase I-II clinical trials of recombinant human interleukin-1 beta as a leukopoiesis stimulator in cancer patients receiving combination chemotherapy

• Published in: European cytokine network (Montrouge) Vol. 12; no. 4; p. 664
• Main Authors: Gershanovich, M L, Filatova, L V, Ketlinsky, S A, Simbirtsev, A S
• Format: Journal Article
• Language: English
• Published: France 01.10.2001
• Subjects: Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Dose-Response Relationship, Drug; Female; Humans; Infusions, Intravenous; Injections, Subcutaneous; Interleukin-1 - administration & dosage; Interleukin-1 - adverse effects; Interleukin-1 - therapeutic use; Leukopenia - chemically induced; Leukopenia - drug therapy; Leukopenia - prevention & control; Male; Middle Aged; Neoplasms - drug therapy; Neoplasms - physiopathology; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use
• ISSN: 1148-5493

Human recombinant interleukin-1 beta (IL-1beta), administered by intravenous drop infusion, at doses of 10-20 ng/kg daily over 5 days, to a group of 67 patients suffering from malignant tumors and with grade II-IV toxic leukopenia, caused an increase in the leukocyte count to the normal value, within, on average, 8 +/- 1 days. The leukostimulatory effect of IL-1beta, administered subcutaneously at an average dose of 4.6 +/- 0.3 ng/kg (n = 16), appeared to be almost equal to that found for intravenous drop infusion at a dose of 10-20 ng/kg (n = 67). In patients receiving subcutaneous IL-1beta injections, the peripheral blood total leukocyte and granulocyte counts achieved normal values within 9 days. The side effects of IL-1beta at a dose of 0.1-20.0 ng/kg were well tolerated.