Pharmacokinetics of Daunorubicin in Young Patients With Cancer

Children's Oncology Group

Status: Completed

Conditions: Unspecified Childhood Solid Tumor, Protocol Specific

Treatments: Other: pharmacological study; Procedure: dual x-ray absorptimetry

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00673257

NCI-2009-00327 (Other Identifier)

CDR0000490024 (Other Identifier)

COG-ABTR06C1 (Other Identifier)

ABTR06C1

Details and patient eligibility

About

This laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. 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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Pharmacokinetics of Daunorubicin chemotherapy patients

Experimental group

Description:

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.

Treatment:

Other: pharmacological study

Procedure: dual x-ray absorptimetry