Status:
WITHDRAWN
Doxorubicin Pharmacokinetic (PK) Study
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Conditions:
Cancer
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00124956
Start Date
June 1 2003
Last Update
September 11 2017
Active Locations (1)
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1
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115