Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00673257
First received: May 6, 2008
Last updated: September 17, 2011
Last verified: November 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: daunorubicin hydrochloride Other: pharmacological study Procedure: dual x-ray absorptometry |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetics of Daunomycin in Children |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Pharmacokinetics
Secondary Outcome Measures:
- Relationship between body composition and the pharmacokinetics of daunorubicin hydrochloride
- Correlation of the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background
- Relationship between pharmacokinetics and toxicity
- Relationship between pharmacokinetics, renal and hepatic function, and complete blood count
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2007 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673257
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Hide Study LocationsLocations
| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016-7710 | |
| United States, California | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5824 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Sacred Heart Cancer Center at Sacred Heart Hospital | |
| Pensacola, Florida, United States, 32504 | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| MBCCOP - Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-3730 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Advocate Christ Medical Center | |
| Oak Lawn, Illinois, United States, 60453 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Masonic Cancer Center at University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89109-2306 | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| United States, Ohio | |
| Akron Children's Hospital | |
| Akron, Ohio, United States, 44308-1062 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37901 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Providence Cancer Center at Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99220-2555 | |
| United States, Wisconsin | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, 3010 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Stacey L. Berg, MD | Texas Children's Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00673257 History of Changes |
| Other Study ID Numbers: | CDR0000490024, COG-ABTR06C1 |
| Study First Received: | May 6, 2008 |
| Last Updated: | September 17, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified childhood solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Daunorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013