Pharmacokinetics of Daunorubicin in Young Patients With Cancer
- Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00673257
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
This laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about how patients respond to treatment with certain chemotherapy drugs.
- Detailed Description
OBJECTIVES:
Primary
* Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.
Secondary
* Evaluate the relationship between body composition (percent body fat) and the pharmacokinetics of daunorubicin hydrochloride in these patients.
* Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background in these patients.
* Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and toxicity.
* Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and renal and hepatic function and complete blood count.
* Explore, in a preliminary fashion, possible genetic polymorphisms that may influence daunorubicin hydrochloride disposition.
OUTLINE: This is a multicenter study.
Patients undergo blood collection prior to, periodically during, and after treatment with daunorubicin hydrochloride for pharmacokinetic analysis.
Patients also undergo body composition testing within 7 days before or after the administration of daunorubicin hydrochloride using dual-energy x-ray absorptiometry.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Population Estimates for Daunorubicin Hydrochloride Clearance Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion. Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.
Population Estimates for Daunorubicin Hydrochloride Volume of Distribution Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion. Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.
- Secondary Outcome Measures
Name Time Method Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride Length of study Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (\<30% versus \>=30%)
Relationship Between Pharmacokinetics, and Genetic Polymorphisms Length of Study Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype
Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background Length of Study Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Gender (Male versus Female), Age group (\<median age versus \>=median age in years), Race (White vs. Black vs. Other)
Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count Length of Study Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values
Relationship Between Pharmacokinetics and Toxicity Length of Study Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities
Trial Locations
- Locations (60)
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Scroll for more (50 remaining)UAB Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States