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
  Purpose

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.


Condition Intervention
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: daunorubicin hydrochloride
Other: pharmacological study
Procedure: dual x-ray absorptimetry

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Daunomycin in Children

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 107
Study Start Date: January 2007
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673257

  Show 60 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Stacey L. Berg, MD Texas Children's Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00673257     History of Changes
Other Study ID Numbers: ABTR06C1, CDR0000490024, COG-ABTR06C1, NCI-2009-00327
Study First Received: May 6, 2008
Results First Received: October 8, 2013
Last Updated: August 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Daunorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014