Doxorubicin Pharmacokinetic (PK) Study
Overview[ - collapse ][ - ]
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. |
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Condition | Cancer |
Intervention | Drug: Doxorubicin |
Phase | Phase 1/Phase 2 |
Sponsor | Children's Hospital Boston |
Responsible Party | Children's Hospital Boston |
ClinicalTrials.gov Identifier | NCT00124956 |
First Received | July 7, 2005 |
Last Updated | January 17, 2006 |
Last verified | January 2006 |
Tracking Information[ + expand ][ + ]
First Received Date | July 7, 2005 |
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Last Updated Date | January 17, 2006 |
Start Date | June 2003 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children |
Current Secondary Outcome Measures | 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) |
Descriptive Information[ + expand ][ + ]
Brief Title | Doxorubicin Pharmacokinetic (PK) Study |
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Official Title | Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1/Phase 2 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Cancer |
Intervention | Drug: Doxorubicin |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 9 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility 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 |
Gender | Both |
Ages | 1 Year |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00124956 |
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Other Study ID Numbers | 03-04-050 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Children's Hospital Boston |
Study Sponsor | Children's Hospital Boston |
Collaborators | Glaser Pediatric Research Network Elizabeth Glaser Pediatric AIDS Foundation |
Investigators | Principal Investigator: Holcombe Grier, MD Dana Farber Cancer Insitute |
Verification Date | January 2006 |
Locations[ + expand ][ + ]
Children's Hospital, Boston | Boston, Massachusetts, United States, 02115 |
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