Status:

COMPLETED

Pharmacokinetics of Daunorubicin in Young Patients With Cancer

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility:

All Genders

Up to 21 years

Phase:

NA

Brief Summary

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...

Detailed Description

OBJECTIVES: Primary * Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy. Secondary * Evaluate the relationship between body composition (percent bo...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 31 2020

    Estimated Enrollment :

    107 Patients enrolled

    Trial Details

    Trial ID

    NCT00673257

    Start Date

    January 1 2007

    End Date

    March 31 2020

    Last Update

    April 14 2020

    Active Locations (60)

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    Page 1 of 15 (60 locations)

    1

    UAB Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294

    2

    Phoenix Children's Hospital

    Phoenix, Arizona, United States, 85016-7710

    3

    Childrens Hospital Los Angeles

    Los Angeles, California, United States, 90027

    4

    Children's Hospital of Orange County

    Orange, California, United States, 92868