Phase I study of recombinant DNA granulocyte macrophage colony stimulating factor.
In this Phase I study of rh GM-CSF three patients have been entered at each of the following dose levels--0.3, 1, 3, 10 and 30 micrograms/kg/day. The mean total white cell count (x 10(9)/l) over the first ten days of rh GM-CSF rose from 11 to 14 at 3 micrograms/kg, 8 to 23 at 10 micrograms/kg and 7 to 27 at 30 micrograms/kg. Side effects included transient pyrexias after the first two infusions of rh GM-CSF and bone pains which were severe and required analgesia in two patients receiving 30 micrograms/kg and one receiving 10 micrograms/kg. No neutralizing antibodies to rh GM-CSF have been detected in the six patients tested to date. Patients are now being studied at 60 micrograms/kg/day.
Steward
W P
WP
CRC Department of Medical Oncology, Christie Hospital, Manchester, U.K.
Scarffe
J H
JH
Austin
R
R
Crowther
D
D
D003115:Colony-Stimulating Factors / Q000627:therapeutic use / Q000633:toxicity*; D015179:Colorectal Neoplasms / Q000188:drug therapy; D004341:Drug Evaluation; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D006133:Growth Substances / Q000627:therapeutic use / Q000633:toxicity*; D006801:Humans; D007958:Leukocyte Count / Q000187:drug effects; D009369:Neoplasms / Q000188:drug therapy*; D009504:Neutrophils / Q000166:cytology / Q000187:drug effects; D011994:Recombinant Proteins / Q000627:therapeutic use / Q000633:toxicity*
D003115:Colony-Stimulating Factors; D006133:Growth Substances; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor