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HEMATOPOIETIC GROWTH FACTOR POTENTIAL FOR TUMOR CELL MOBILIZATION

Executive Summary

HEMATOPOIETIC GROWTH FACTOR POTENTIAL FOR TUMOR CELL MOBILIZATION is an issue that should be considered when designing clinical trials of HGFs as supportive therapy for myelotoxic treatments, FDA Clinical Trial Design Division Director Jay Siegel, MD, observed during the Biological Response Modifiers Advisory Committee meeting Dec. 8. Summarizing the committee's discussion of the potential for peripheral blood progenitor cell (PBPC) mobilizing agents to stimulate tumor cells, Siegel said: "Where one finds an increase in cells one should take that very seriously." He added that there might be situations "where one can exclude an increase in tumor cells."

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