Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about how patients respond to treatment with certain chemotherapy drugs.
PURPOSE: This laboratory study is looking at the pharmacokinetics of daunorubicin in treating young patients with cancer.
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: daunorubicin hydrochloride
Other: pharmacological study
Procedure: dual x-ray absorptometry
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics of Daunomycin in Children|
- Relationship between body composition and the pharmacokinetics of daunorubicin hydrochloride
- Correlation of the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background
- Relationship between pharmacokinetics and toxicity
- Relationship between pharmacokinetics, renal and hepatic function, and complete blood count
|Study Start Date:||January 2007|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
- Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.
- 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.