Pharmacokinetics of Daunorubicin in Young Patients With Cancer
NCT ID: NCT00673257
Last Updated: 2020-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2007-01-31
2020-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Pharmacokinetics of Daunorubicin chemotherapy patients
Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
pharmacological study
pharmacological studies
dual x-ray absorptimetry
Interventions
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pharmacological study
pharmacological studies
dual x-ray absorptimetry
Other Intervention Names
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Eligibility Criteria
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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
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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Stacey L. Berg, MD
Role: STUDY_CHAIR
Texas Children's Cancer Center
Locations
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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 D.C., 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
St. 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
St 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
Countries
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Other Identifiers
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CDR0000490024
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ABTR06C1
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00327
Identifier Type: OTHER
Identifier Source: secondary_id
ABTR06C1
Identifier Type: -
Identifier Source: org_study_id
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