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The conduct of phase I-II clinical trials in children with cancer
1Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN 38105.
Abstract:
Phase I Clinical Trials in children with cancer are carried out with therapeutic intent, so as to define antileukemic/antitumor activity, dose-limiting toxicity, maximum tolerated dosage, and pharmacokinetics. These studies define a dosage of an agent or combination that may be used in a larger study of pediatric patients with leukemias or malignant solid tumors. The content of phase I and II protocols is outlined, with a brief discussion of the ethics of performance of phase I trials in children.
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