Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00673257
First received: May 6, 2008
Last updated: August 7, 2014
Last verified: August 2014

May 6, 2008
August 7, 2014
January 2007
July 2011   (final data collection date for primary outcome measure)
  • Population Estimates for Daunorubicinol Clearance [ Time Frame: prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion. ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.
  • Population Estimates for Daunorubicinol Volume of Distribution [ Time Frame: prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion. ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.
Pharmacokinetics
Complete list of historical versions of study NCT00673257 on ClinicalTrials.gov Archive Site
Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Multivariate analysis of the data will also be performed. Assess the significance of the relationship between the following characteristics: BMI, BSA, ALT, bilirubin, age, gender, and ethnicity, and daunomycin PK parameters.
  • 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: Pharmacokinetics of Daunorubicin chemotherapy patients
Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
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.
 
Active, not recruiting
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, NCI-2009-00327
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
August 2014

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