The conduct of phase I-II clinical trials in children with cancer.
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.
Pratt
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Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN 38105.
D002648:Child; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods*; D004341:Drug Evaluation / Q000379:methods*; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D007938:Leukemia / Q000188:drug therapy; D009369:Neoplasms / Q000188:drug therapy*