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Clinical and Epidemiological Investigations

Phase I Trial and Pharmacokinetic Evaluation of Fazarabine in Children

Richard L. Heideman, Andrea Gillespie, Harry Ford, Gregory H. Reaman, Frank M. Balis, Charlotte Tan, Judy Sato, Lawrence J. Ettinger, Roger J. Packer and David G. Poplack
Richard L. Heideman
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Andrea Gillespie
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Harry Ford
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Gregory H. Reaman
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Frank M. Balis
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Charlotte Tan
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Judy Sato
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Lawrence J. Ettinger
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Roger J. Packer
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David G. Poplack
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DOI:  Published September 1989
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Abstract

A phase I trial of fazarabine (1-β-d-arabinofuranosyl-5-azacytosine, NSC 281272) administered as a 24-h continuous infusion was performed in 16 children with refractory malignancies. Dose-limiting toxicity consisting of reversible granulocytopenia and thrombocytopenia was observed in 4 of 4 solid tumor patients treated at the starting dose of 20 mg/m2/h. Subsequent patients were treated at a dose of 15 mg/m2/h which was determined to be the maximum tolerated dose. Moderate nausea and vomiting were the only other toxicities observed. Plasma steady-state concentrations of fazarabine were attained by 2–4 h in all patients and were 1.8 and 2.5 µm at the 15- and 20-mg/m2/h doses, respectively. The total body clearance of fazarabine was 571 and 550 ml/min/m2 at the 15- and 20-mg/m2/h doses, respectively. In three of four patients evaluated, fazarabine was detectable in the cerebrospinal fluid (CSF). Steady-state CSF concentrations ranged from 0.29 to 0.74 µm in these three individuals and the steady-state CSF:plasma ratios ranged from 0.22–0.25. Both the plasma and CSF steady-state concentrations were within the 0.1 to 1 µm range reported to be cytotoxic in vitro against the Molt-4 human T-lymphoblastic leukemia cell line. Based on the above, the optimal dose for phase II trials of fazarabine administered as a 24-h infusion is 15 mg/m2/h (360 mg/m2/day).

Footnotes

  • ↵2 To whom requests for reprints should be addressed at National Cancer Institute, Building 10, Room 13N 240, Bethesda, MD 20892.

  • Received January 30, 1989.
  • Revision received May 26, 1989.
  • Accepted June 15, 1989.
  • ©1989 American Association for Cancer Research.
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September 1989
Volume 49, Issue 18
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Phase I Trial and Pharmacokinetic Evaluation of Fazarabine in Children
Richard L. Heideman, Andrea Gillespie, Harry Ford, Gregory H. Reaman, Frank M. Balis, Charlotte Tan, Judy Sato, Lawrence J. Ettinger, Roger J. Packer and David G. Poplack
Cancer Res September 15 1989 (49) (18) 5213-5216;

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Phase I Trial and Pharmacokinetic Evaluation of Fazarabine in Children
Richard L. Heideman, Andrea Gillespie, Harry Ford, Gregory H. Reaman, Frank M. Balis, Charlotte Tan, Judy Sato, Lawrence J. Ettinger, Roger J. Packer and David G. Poplack
Cancer Res September 15 1989 (49) (18) 5213-5216;
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