Spots Global Cancer Trial Database for Pharmacokinetics of Daunorubicin in Young Patients With Cancer
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Trial Identification
Brief Title: Pharmacokinetics of Daunorubicin in Young Patients With Cancer
Official Title: Pharmacokinetics of Daunomycin in Children
Study ID: NCT00673257
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Akron Children's Hospital, Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Hopital Sainte Justine, Montreal, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Contact Details
Name: Stacey L. Berg, MD
Affiliation: Texas Children's Cancer Center
Role: STUDY_CHAIR
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