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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This study has been withdrawn prior to enrollment.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
July 7, 2005
July 29, 2005
September 11, 2017
June 2003
Not Provided
To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children
To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children.
Complete list of historical versions of study NCT00124956 on ClinicalTrials.gov Archive Site
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)
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).
Not Provided
Not Provided
 
Doxorubicin Pharmacokinetic (PK) Study
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
Drug: Doxorubicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Sexes Eligible for Study: All
1 Year to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00124956
03-04-050
Not Provided
Not Provided
Not Provided
Steven Dubois, Dana-Farber Cancer Institute
Boston Children’s Hospital
  • Glaser Pediatric Research Network
  • Elizabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Holcombe Grier, MD Dana Farber Cancer Insitute
Boston Children’s Hospital
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP