Pharmacokinetics of Daunomycin in Children
N/A
21 Years
Both
Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Pharmacokinetics of Daunomycin in Children
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of any malignancy
- Must be receiving a chemotherapy regimen that includes daunorubicin hydrochloride
administered as an infusion of any duration for < 24 hours on either a 1- or a 2-day
schedule, including bolus and all short infusion schedules
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- No significant uncontrolled systemic illness
- Large implanted prostheses allowed (should not undergo dual energy x-ray
absorptiometry scan)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetics
Outcome Time Frame:
Length of study
Safety Issue:
No
Principal Investigator
Stacey L. Berg, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Texas Children's Cancer Center
Authority:
United States: Federal Government
Study ID:
ABTR06C1
NCT ID:
NCT00673257
Start Date:
January 2007
Completion Date:
Related Keywords:
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
| Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
| East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53226 |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Advocate Christ Medical Center | Oak Lawn, Illinois 60453 |
| Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
| Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
| Childrens Hospital Los Angeles | Los Angeles, California 90027 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
| Akron Children's Hospital | Akron, Ohio 44308-1062 |
| Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Stanford Cancer Center | Stanford, California 94305-5824 |
