Doxorubicin Pharmacokinetic (PK) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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This protocol is designed to obtain detailed information on the impact of body composition on the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21 years of age or younger. There is no efficacy component. Approximately 9 children will be enrolled at Children's Hospital Boston. The information gained from this study could be very important in developing dosing strategies for doxorubicin in the obese patient population.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Doxorubicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Eligible patients will be \> 1 and ≤ 21 years old.
* All patients must be receiving chemotherapy that includes doxorubicin administered as an infusion of any duration \< 24 hours, on either a 1-day or 2-day schedule. This includes bolus and all short infusion schedules.
* All patients or their parents/legal guardians will provide informed consent/assent (as required by law) indicating their awareness of the investigational nature and the risks of this study according to the informed consent process.

Exclusion Criteria

* Women who are known to be pregnant or lactating
* Patients with significant uncontrolled systemic illness
* Serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvate transaminase (SGPT/ALT) \> 3 times the upper limit of normal tested within 14 days prior to infusion
* Bilirubin \> the upper limit of normal tested within 14 days prior to infusion
* Patients whose dose of doxorubicin is based on ideal body weight
* Patients who weigh \< 12 kilograms at time of screening

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No