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Summary

for people ages up to 21 years
at San Francisco, California and other locations
study started

Description

Summary

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.

Official Title

Pharmacokinetics of Daunomycin in Children

Details

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.

Keywords

Unspecified Childhood Solid Tumor, Protocol Specific Daunorubicin

Eligibility

For people ages up to 21 years

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

Locations

  • Stanford Cancer Center
    Stanford, California, 94305-5824, United States
  • Childrens Hospital Los Angeles
    Los Angeles, California, 90027, United States
  • Children's Hospital of Orange County
    Orange, California, 92868, United States
  • CCOP - Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89109-2306, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT00673257
Study Type
Interventional
Last Updated
September 1, 2016