The conduct of phase I-II clinical trials in children with cancer
โ Scribed by Pratt, Charles B.
- Publisher
- John Wiley and Sons
- Year
- 1991
- Tongue
- English
- Weight
- 677 KB
- Volume
- 19
- Category
- Article
- ISSN
- 0098-1532
No coin nor oath required. For personal study only.
โฆ Synopsis
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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## Abstract Rubidazone was administered to 24 children with advanced solid tumors or leukemia. The dose ranged from 80 to 150 mg/m^2^/IV daily to a total dose of 160 to 450 mg/m^2^/course. This course was repeated at intervals of approximately three weeks. Eighteen of 24 patients (75%) had received
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