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Phase I trial of recombinant human macrophage colony-stimulating factor in
patients with invasive fungal infections
J Nemunaitis, JD Meyers, CD Buckner, K Shannon-Dorcy, M Mori, H Shulman, JA Bianco, CS Higano, E Groves and R Storb
Fred Hutchinson Cancer Research Center, Veterans Affairs Medical Center,
University of Washington, Seattle.
A phase I dose escalation trial of recombinant human macrophage colony-
stimulating factor (rhM-CSF) in combination with conventional antifungal
therapy was conducted in 24 marrow transplant recipients with invasive
fungal infection. Daily doses ranged from 100 to 2,000 micrograms/m2/d.
Toxicity, such as constitutional symptoms, directly ascribed to rhM-CSF was
not observed; however, transient, dose-related thrombocytopenia was
observed. Patients who received 2,000 micrograms/m2/d of rhM-CSF had a mean
reduction in platelet count of 61,000/mm3 during the rhM-CSF infusion
period, which was significant when compared with patients who received
lower doses of rhM-CSF (P = .008). Fourteen of the 16 patients who received
rhM-CSF after undergoing allogeneic bone marrow transplantation had no
change in the severity of graft-versus-host disease (GVHD) while receiving
rhM-CSF. One had an increase in the severity of GVHD and one had a
decrease. There were no effects on neutrophil, monocyte, or lymphocyte
counts. Six patients had resolution of their infections, 12 were not
evaluable for response, and six did not respond. Ten patients survived 100
days after initiation of rhM-CSF and 14 died. Further trials with rhM-CSF
to assess antifungal activity are indicated.
Volume 78,
Issue 4,
pp. 907-913,
08/15/1991
Copyright © 1991 by The American Society of Hematology
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