Expired Study
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Boston, Massachusetts 02115


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.


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


NCT ID:

NCT00124956


Primary Contact:

Principal Investigator
Holcombe Grier, MD
Dana Farber Cancer Insitute


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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