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Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Unspecified Childhood Solid Tumor, Protocol Specific

Intervention: daunorubicin hydrochloride (Drug); pharmacological study (Other); dual x-ray absorptimetry (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Stacey L. Berg, MD, Study Chair, Affiliation: Texas Children's Cancer Center


RATIONALE: 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. PURPOSE: This laboratory study is looking at the pharmacokinetics of daunorubicin in treating young patients with cancer.

Clinical Details

Official title: Pharmacokinetics of Daunomycin in Children

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

Primary outcome:

Population Estimates for Daunorubicinol Clearance

Population Estimates for Daunorubicinol Volume of Distribution

Secondary outcome: Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count

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.


Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.



- 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

Locations and Contacts

Swiss Pediatric Oncology Group Bern, Bern 3010, Switzerland

UAB Comprehensive Cancer Center, Birmingham, Alabama 35294, United States

Phoenix Children's Hospital, Phoenix, Arizona 85016-7710, United States

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States

Children's Hospital of Orange County, Orange, California 92868, United States

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States

Stanford Cancer Center, Stanford, California 94305-5824, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida 33607, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia 30322, United States

MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912-3730, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States

Advocate Christ Medical Center, Oak Lawn, Illinois 60453, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States

Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky 40536-0093, United States

Kosair Children's Hospital, Louisville, Kentucky 40232, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan 48109-0286, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri 63110, United States

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89109-2306, United States

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico 87131-5636, United States

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States

Akron Children's Hospital, Akron, Ohio 44308-1062, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States

Nationwide Children's Hospital, Columbus, Ohio 43205-2696, United States

Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States

Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon 97239-3098, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan S7N 4H4, Canada

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina 29425, United States

East Tennessee Children's Hospital, Knoxville, Tennessee 37901, United States

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States

Baylor University Medical Center - Houston, Houston, Texas 77030-2399, United States

M. D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington 99220-2555, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2007
Last updated: August 7, 2014

Page last updated: August 20, 2015

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