Doxorubicin Pharmacokinetic (PK) Study

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00124956

Run by

Boston Children's Hospital

People needed

0

Starts

2003-06-01

Last updated by the study team

2017-09-11

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.