This protocol 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 9 children will be
enrolled at Children's Hospital Boston. The information gained from this study could be very
important in developing dosing strategies for doxorubicin in the obese patient population.
- Eligible patients will be > 1 and ≤ 21 years old.
- All patients must be receiving chemotherapy that includes doxorubicin administered as
an infusion of any duration < 24 hours, on either a 1-day or 2-day schedule. This
includes bolus and all short infusion schedules.
- All patients or their parents/legal guardians will provide informed consent/assent (as
required by law) indicating their awareness of the investigational nature and the
risks of this study according to the informed consent process.
- Women who are known to be pregnant or lactating
- Patients with significant uncontrolled systemic illness
- Serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvate
transaminase (SGPT/ALT) > 3 times the upper limit of normal tested within 14 days
prior to infusion
- Bilirubin > the upper limit of normal tested within 14 days prior to infusion
- Patients whose dose of doxorubicin is based on ideal body weight
- Patients who weigh < 12 kilograms at time of screening