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Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients


Phase 1/Phase 2
1 Year
21 Years
Not Enrolling
Both
Cancer

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Trial Information

Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children

Principal Investigator

Holcombe Grier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana Farber Cancer Insitute

Authority:

United States: Institutional Review Board

Study ID:

03-04-050

NCT ID:

NCT00124956

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Cancer

Name

Location

Children's Hospital, BostonBoston, Massachusetts  02115