Doxorubicin Pharmacokinetic (PK) Study

Boston Children's Hospital

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Cancer

Treatments

Drug: Doxorubicin

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT00124956

03-04-050

Details and patient eligibility

About

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.

Sex

All

Ages

1 to 21 years old

Volunteers

No Healthy Volunteers

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