Evaluating Dactinomycin and Vincristine in Young Patients With Cancer
NCT ID: NCT00674193
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
158 participants
OBSERVATIONAL
2008-02-29
Brief Summary
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Detailed Description
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I. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.
II. To identify demographic or physiological factors that are determinants of dactinomycin disposition.
III. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.
IV. To identify demographic or physiological factors that are determinants of VCR disposition.
SECONDARY OBJECTIVES:
I. To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.
II. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer.
OUTLINE: This is a multicenter study.
Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.
After the final pharmacokinetic sample is collected, patients are followed for up to 6 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (pharmacological study)
Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Interventions
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pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute lymphoblastic leukemia
* Ewing sarcoma
* Rhabdomyosarcoma
* Soft tissue sarcoma
* Wilms tumor
* Due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
* Able to comply with study requirements
* Other concurrent chemotherapeutic agents allowed
16 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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Jeffrey Skolnik
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Childrens Hospital of Orange County
Orange, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States
Nemours Childrens Clinic - Orlando
Orlando, Florida, United States
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, United States
University of Illinois
Chicago, Illinois, United States
Childrens Memorial Hospital
Chicago, Illinois, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Mission Hospitals Inc
Asheville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Hospital Sainte-Justine
Montreal, Quebec, Canada
Countries
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Other Identifiers
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NCI-2009-00362
Identifier Type: REGISTRY
Identifier Source: secondary_id
COG-ADVL06B1
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000559243
Identifier Type: OTHER
Identifier Source: secondary_id
ADVL06B1
Identifier Type: -
Identifier Source: org_study_id
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