Phase I trial of recombinant human macrophage colony-stimulating factor in patients with invasive fungal infections

J. Nemunaitis, J. D. Meyers, C. D. Buckner, K. Shannon-Dorcy, Motomi (Tomi) Mori, H. Shulman, J. A. Bianco, C. S. Higano, E. Groves, R. Storb, J. Hansen, F. R. Appelbaum, J. W. Singer

Research output: Contribution to journalArticle

124 Citations (Scopus)

Abstract

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 μg/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 μg/ 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 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.

Original languageEnglish (US)
Pages (from-to)907-913
Number of pages7
JournalBlood
Volume78
Issue number4
StatePublished - Aug 15 1991
Externally publishedYes

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Macrophage Colony-Stimulating Factor
Graft vs Host Disease
Grafts
Transplantation (surgical)
Invasive Fungal Infections
Transplants
Lymphocytes
Homologous Transplantation
Lymphocyte Count
Platelets
Bone Marrow Transplantation
Platelet Count
Thrombocytopenia
Toxicity
Monocytes
Bone
Neutrophils
Bone Marrow

ASJC Scopus subject areas

  • Hematology

Cite this

Nemunaitis, J., Meyers, J. D., Buckner, C. D., Shannon-Dorcy, K., Mori, M. T., Shulman, H., ... Singer, J. W. (1991). Phase I trial of recombinant human macrophage colony-stimulating factor in patients with invasive fungal infections. Blood, 78(4), 907-913.

Phase I trial of recombinant human macrophage colony-stimulating factor in patients with invasive fungal infections. / Nemunaitis, J.; Meyers, J. D.; Buckner, C. D.; Shannon-Dorcy, K.; Mori, Motomi (Tomi); Shulman, H.; Bianco, J. A.; Higano, C. S.; Groves, E.; Storb, R.; Hansen, J.; Appelbaum, F. R.; Singer, J. W.

In: Blood, Vol. 78, No. 4, 15.08.1991, p. 907-913.

Research output: Contribution to journalArticle

Nemunaitis, J, Meyers, JD, Buckner, CD, Shannon-Dorcy, K, Mori, MT, Shulman, H, Bianco, JA, Higano, CS, Groves, E, Storb, R, Hansen, J, Appelbaum, FR & Singer, JW 1991, 'Phase I trial of recombinant human macrophage colony-stimulating factor in patients with invasive fungal infections', Blood, vol. 78, no. 4, pp. 907-913.
Nemunaitis J, Meyers JD, Buckner CD, Shannon-Dorcy K, Mori MT, Shulman H et al. Phase I trial of recombinant human macrophage colony-stimulating factor in patients with invasive fungal infections. Blood. 1991 Aug 15;78(4):907-913.
Nemunaitis, J. ; Meyers, J. D. ; Buckner, C. D. ; Shannon-Dorcy, K. ; Mori, Motomi (Tomi) ; Shulman, H. ; Bianco, J. A. ; Higano, C. S. ; Groves, E. ; Storb, R. ; Hansen, J. ; Appelbaum, F. R. ; Singer, J. W. / Phase I trial of recombinant human macrophage colony-stimulating factor in patients with invasive fungal infections. In: Blood. 1991 ; Vol. 78, No. 4. pp. 907-913.
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abstract = "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 μg/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 μg/ 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 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.",
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