Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00673257

First received: May 6, 2008

Last updated: September 17, 2011

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 6, 2008

Last Updated Date

September 17, 2011

Start Date ^ICMJE

January 2007

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00673257 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer

Official Title ^ICMJE

Pharmacokinetics of Daunomycin in Children

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: daunorubicin hydrochloride
Other: pharmacological study
Procedure: dual x-ray absorptometry

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00673257

Other Study ID Numbers ^ICMJE

CDR0000490024, COG-ABTR06C1

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Stacey L. Berg, MD

Texas Children's Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2010

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

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