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The conduct of phase I-II clinical trials in children with cancer.

Authors
Type
Published Article
Journal
Medical and pediatric oncology
Publication Date
Volume
19
Issue
4
Pages
304–309
Identifiers
PMID: 2056975
Source
Medline

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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