Recombinant human interleukin 4 (IL-4) given as daily subcutaneous injections--a phase I dose toxicity trial.
Recombinant Interleukin 4 was administered by subcutaneous injection at daily doses of 0.5, 1.0 or 5.0 micrograms kg-1 to nine patients as part of a Phase I Dose Toxicity Study. Dose limiting toxicity was reached at 5 micrograms kg-1 day-1. Symptoms of toxicity included fatigue, 'flu like symptoms and elevated liver enzymes. Modest but significant elevations of neutrophil and platelet counts occurred. No clear evidence of antitumour effects emerged although pain in metastatic lymph nodes and a small fall in myeloma paraprotein levels during dosing were observed. In vitro and murine in vivo studies indicate that patients with lymphoproliferative disease should be selected for Phase II trials.
Gilleece
M H
MH
Cancer Research Campaign, Department of Experimental Haematology, Christie Hospital NHS Trust, Manchester, U.K.
Scarffe
J H
JH
Ghosh
A
A
Heyworth
C M
CM
Bonnem
E
E
Testa
N
N
Stern
P
P
Dexter
T M
TM
D001853:Bone Marrow / Q000276:immunology / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007279:Injections, Subcutaneous; D015847:Interleukin-4 / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use / Q000633:toxicity*; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010976:Platelet Count / Q000187:drug effects; D019948:Receptors, Interleukin-4; D011975:Receptors, Mitogen / Q000032:analysis; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use / Q000633:toxicity
D007074:Immunoglobulin G; D019948:Receptors, Interleukin-4; D011975:Receptors, Mitogen; D011994:Recombinant Proteins; D015847:Interleukin-4