Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00673257
First received: May 6, 2008
Last updated: May 29, 2013
Last verified: May 2013

May 6, 2008
May 29, 2013
January 2007
July 2011   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Pharmacokinetics
Complete list of historical versions of study NCT00673257 on ClinicalTrials.gov Archive Site
  • Relationship between body composition and the pharmacokinetics of daunorubicin hydrochloride [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Correlation of the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Relationship between pharmacokinetics and toxicity [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Relationship between pharmacokinetics, renal and hepatic function, and complete blood count [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer
Pharmacokinetics of Daunomycin in Children

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Childhood Solid Tumor, Protocol Specific
  • Drug: daunorubicin hydrochloride
    Given IV
    Other Names:
    • Daunomycin
    • rubidomycin
    • Cerubidine
    • NSC #82151
  • Other: pharmacological study
    pharmacological studies
  • Procedure: dual x-ray absorptimetry
    Other Names:
    • DEXA scan
    • dual energy x-ray absorptimetry
Experimental: Arm I
Patients undergo blood collection prior to, periodically during, and after treatment with daunorubicin hydrochloride for pharmacological study. Patients also undergo body composition testing within 7 days before or after the administration of daunorubicin hydrochloride using dual x-ray absorptimetry
Interventions:
  • Drug: daunorubicin hydrochloride
  • Other: pharmacological study
  • Procedure: dual x-ray absorptimetry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
Not Provided
July 2011   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Switzerland
 
NCT00673257
ABTR06C1, CDR0000490024, COG-ABTR06C1
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Stacey L. Berg, MD Texas Children's Cancer Center
Children's Oncology Group
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP