Overview

This trial is active, not recruiting.

Condition unspecified childhood solid tumor, protocol specific
Treatments daunorubicin hydrochloride, pharmacological study, dual x-ray absorptimetry
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date January 2007
End date July 2011
Trial size 107 participants
Trial identifier NCT00673257, ABTR06C1, CDR0000490024, COG-ABTR06C1, NCI-2009-00327

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
daunorubicin hydrochloride Daunomycin
Given IV
pharmacological study
pharmacological studies
dual x-ray absorptimetry DEXA scan

Primary Outcomes

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.
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.

Secondary Outcomes

Measure
Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count
time frame: Length of study

Eligibility Criteria

Male or female participants up to 21 years old.

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

Additional Information

Official title Pharmacokinetics of Daunomycin in Children
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Children's Oncology Group.