IMPACT OF BODY COMPOSITION ON PHARMACOKINETICS OF DOXORUBICIN

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Glaser Pediatric Research Network, an innovative and collaborative partnership, linking scientific centers to accelerate progress on serious and life-threatening pediatric illnesses. A primary objective of the Glaser Pediatric Research Network is to ensure that, as new therapies are developed, physicians learn more quickly about their pediatric applications. The participating centers are BCM, Harvard, Stanford, UCLA, UCSF.The pharmacokinetic behavior of doxorubicin as it relates to body mass index and body composition has not been well characterized. This protocol, being performed within the Glaser Pediatric Research Network, is designed to obtain detailed information on the impact of body composition on the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21 years of age or younger. There is no efficacy component. Approximately 45 children will be enrolled. The information gained from this study could be very important in developing dosing strategies for doxorubicin in the obese patient population. HYPOTHESIS Body composition may affect the pharmacokinetic parameters of doxorubicin. In particular, patients who are obese by body mass index criteria or who have a high percentage of body fat as measured by DEXA scanning may have decreased doxorubicin clearance. SPECIFIC AIMSPrimary: To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children.Secondary: To determine body composition in children who are categorized as obese/non-obese based on body mass index (BMI).