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.
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.
Gershanovich
M L
ML
N.N. Petrov Research Institute of Oncology, St. Petersburg, 197110, Russia.
Filatova
L V
LV
Ketlinsky
S A
SA
Simbirtsev
A S
AS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D007375:Interleukin-1 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007970:Leukopenia / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
D007375:Interleukin-1; D011994:Recombinant Proteins