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.