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Cancer Treat Rep. 1986 Jun;70(6):703-9.

Phase I study of ICRF-187 in pediatric cancer patients and comparison of its pharmacokinetics in children and adults.

Cancer treatment reports

J S Holcenberg, K D Tutsch, R H Earhart, R S Ungerleider, B A Kamen, C B Pratt, T J Gribble, D L Glaubiger

PMID: 3089595

Abstract

A phase I study of ICRF-187 as a 2-hour iv infusion daily for 3 days was conducted in 46 evaluable pediatric patients. The maximum tolerated dose was 3500 mg/m2/day X 3 based on changes in hepatic function and coagulation abnormalities encountered when larger dosages were administered. One patient with acute lymphocytic leukemia achieved a complete remission and four cleared the blood of lymphoblasts. No other objective responses were seen. Pharmacokinetic analysis showed that the children had a larger volume of distribution per kilogram of body weight in the central compartment and total body and a more rapid total-body clearance than adults. These parameters can explain only part of the increased tolerance of children to ICRF-187.

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