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Pharmacokinetics of Daunomycin in Children

21 Years
Not Enrolling
Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Pharmacokinetics of Daunomycin in Children



- Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with


- 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


- 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


- Not pregnant or nursing

- No significant uncontrolled systemic illness

- Large implanted prostheses allowed (should not undergo dual energy x-ray
absorptiometry scan)


- See Disease Characteristics

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

Length of study

Safety Issue:


Principal Investigator

Stacey L. Berg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific



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