Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer

OBJECTIVES:

Primary

- Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with
malignancy.

Secondary

- Evaluate the relationship between body composition (percent body fat) and the
pharmacokinetics of daunorubicin hydrochloride in these patients.

- Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or
ethnic background in these patients.

- Explore, in a preliminary fashion, possible relationships between pharmacokinetic
results and toxicity.

- Explore, in a preliminary fashion, possible relationships between pharmacokinetic
results and renal and hepatic function and complete blood count.

- Explore, in a preliminary fashion, possible genetic polymorphisms that may influence
daunorubicin hydrochloride disposition.

OUTLINE: This is a multicenter study.

Patients undergo blood collection prior to, periodically during, and after treatment with
daunorubicin hydrochloride for pharmacokinetic analysis.

Patients also undergo body composition testing within 7 days before or after the
administration of daunorubicin hydrochloride using dual-energy x-ray absorptiometry.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Diagnosis of any malignancy

- Must be receiving a chemotherapy regimen that includes daunorubicin hydrochloride
administered as an infusion of any duration for < 24 hours on either a 1- or a 2-day
schedule, including bolus and all short infusion schedules

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- No significant uncontrolled systemic illness

- Large implanted prostheses allowed (should not undergo dual energy x-ray
absorptiometry scan)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics