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Doxorubicin Pharmacokinetic (PK) Study

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124956
First Posted: July 29, 2005
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by (Responsible Party):
Steven Dubois, Dana-Farber Cancer Institute
  Purpose
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.

Condition Intervention Phase
Cancer Drug: Doxorubicin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Steven Dubois, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children

Secondary Outcome Measures:
  • 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)

Enrollment: 0
Study Start Date: June 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124956


Locations
United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Investigators
Principal Investigator: Holcombe Grier, MD Dana Farber Cancer Insitute
  More Information

Responsible Party: Steven Dubois, Associate Professor of Pediatrics, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00124956     History of Changes
Other Study ID Numbers: 03-04-050
First Submitted: July 7, 2005
First Posted: July 29, 2005
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action