Doxorubicin Pharmacokinetic (PK) Study

September 7, 2017 updated by: Steven Dubois, Boston Children's Hospital

Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital, Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children

Secondary Outcome Measures

Outcome Measure
To explore the relationship between PK parameters and the patients' characteristics (age, gender, and ethnicity) and to correlate between PK parameters and DXA data (fat mass, lean tissue mass, and bone mineral content)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Elizabeth Glaser Pediatric AIDS Foundation
Glaser Pediatric Research Network

Investigators

  • Principal Investigator: Holcombe Grier, MD, Dana Farber Cancer Insitute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Registration Dates

First Submitted

July 7, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

July 29, 2005

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-04-050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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