Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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