Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Pharmacokinetics of Daunomycin in Children
This laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. 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.
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.
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