Doxorubicin Pharmacokinetic (PK) Study

NCT00124956 | Withdrawn Phase 1

• 1 other identifier: 03-04-050
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children

Secondary Outcomes (1)

• To explore the relationship between PK parameters and the patients' characteristics (age, gender, and ethnicity) and to correlate between PK parameters and DXA data (fat mass, lean tissue mass, and bone mineral content)

Interventions

Doxorubicin DRUG

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Glaser Pediatric Research Network: collaborator
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator

Study Sites (1)

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Doxorubicin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Holcombe Grier, MD

  Dana Farber Cancer Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 7, 2005
• First Posted: July 29, 2005
• Study Start: June 1, 2003
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)