Evaluating Dactinomycin and Vincristine in Young Patients With Cancer
- Conditions
- Ewing Sarcoma of BoneEwing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)Unspecified Childhood Solid Tumor, Protocol SpecificChildhood Acute Lymphoblastic LeukemiaChildhood Soft Tissue SarcomaChildhood RhabdomyosarcomaEwing SarcomaWilms Tumor and Other Childhood Kidney Tumors
- Interventions
- Other: pharmacological studyOther: laboratory biomarker analysis
- Registration Number
- NCT00674193
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.
- Detailed Description
PRIMARY OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
-
Diagnosis of cancer, including, but not limited to, any of the following:
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational (pharmacological study) laboratory biomarker analysis 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. Observational (pharmacological study) 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.
- Primary Outcome Measures
Name Time Method Population PK parameters for dactinomycin and VCR Not Provided Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition Not Provided
- Secondary Outcome Measures
Name Time Method Pharmacogenetic profiles of patients receiving dactinomycin and VCR Not Provided Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children Not Provided Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes Not Provided Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR) Not Provided Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes Not Provided
Trial Locations
- Locations (38)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Rainbow Babies and Childrens Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
Nemours Children's Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Children's National Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Childrens Hospital of Orange County
🇺🇸Orange, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Hospital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
University of Illinois
🇺🇸Chicago, Illinois, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Advocate Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
East Tennessee Childrens Hospital
🇺🇸Knoxville, Tennessee, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Mission Hospitals Inc
🇺🇸Asheville, North Carolina, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Childrens Memorial Hospital
🇺🇸Chicago, Illinois, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Francisco Medical Center-Parnassus
🇺🇸San Francisco, California, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Nemours Childrens Clinic - Orlando
🇺🇸Orlando, Florida, United States
Saint Joseph Children's Hospital of Tampa
🇺🇸Tampa, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
C S Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States