Recombinant human granulocyte-macrophage colony-stimulating factor in patients with myelodysplastic syndromes--a phase-I/II trial.
A phase-I/II trial was initiated to study the effect of rhGM-CSF in patients with myelodysplastic syndromes who were not eligible for other kinds of therapy, rhGM-CSF was given to 9 patients in doses of 15 micrograms/m2-150 micrograms/m2 as an intravenous 8-h infusion for a cycle of 7 days followed by an interval of 14 days and a second 7-day treatment course. A dose-dependent increase in the leukocyte count was observed in 7 out of 9 patients. No change in reticulocyte numbers was seen and only 1 patient experienced an increase in platelet count. Toxicity mainly consisted of mild local phlebitis at the site of infusion and sternal pain after bolus injection.
Ganser
A
A
Dept. of Hematology, University of Frankfurt, FRG.
Völkers
B
B
Greher
J
J
Walther
F
F
Hoelzer
D
D
D000368:Aged; D003115:Colony-Stimulating Factors / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D006133:Growth Substances / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000628:therapy*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use*
D003115:Colony-Stimulating Factors; D006133:Growth Substances; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor