Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)
Pharmacogenetic profiles of patients receiving dactinomycin and VCR
Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children
Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes
Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes
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.
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| U.S.A. |
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| Alabama |
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Birmingham |
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| | UAB Comprehensive Cancer Center |
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| | Clinical Trials Office - UAB Comprehensive Cancer Center | |
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| Arkansas |
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Little Rock |
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| | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences |
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| | Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
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| California |
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Los Angeles |
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| | Childrens Hospital Los Angeles |
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| | Leo Mascarenhas | |
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Orange |
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| | Children's Hospital of Orange County |
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| | Violet Shen | |
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San Francisco |
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| | UCSF Helen Diller Family Comprehensive Cancer Center |
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| | Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center | |
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| Delaware |
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Wilmington |
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| | Alfred I. duPont Hospital for Children |
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| | Clinical Trials Office - Alfred I. duPont Hospital for Children | |
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| Florida |
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Jacksonville |
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| | Nemours Children's Clinic |
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| | Eric Sandler | |
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Tampa |
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| | St. Joseph's Cancer Institute at St. Joseph's Hospital |
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| | Clinical Trials Office - St. Joseph's Cancer Institute | |
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| Georgia |
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Atlanta |
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| | Winship Cancer Institute of Emory University |
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| | Howard Katzenstein | |
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| Illinois |
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Chicago |
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| | Children's Memorial Hospital - Chicago |
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| | Stewart Goldman | |
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Oak Lawn |
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| | Advocate Christ Medical Center |
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| | Sharad Salvi | |
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| Indiana |
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Indianapolis |
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| | St. Vincent Indianapolis Hospital |
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| | Clinical Trials Office - St. Vincent Indianapolis Hospital | |
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| Kentucky |
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Lexington |
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| | Lucille P. Markey Cancer Center at University of Kentucky |
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| | Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center | |
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Louisville |
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| | Kosair Children's Hospital |
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| | Clinical Trials Office - Kosair Children's Hospital | |
| | Email:
CancerResource@nortonhealthcare.org |
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| Michigan |
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Ann Arbor |
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| | C.S. Mott Children's Hospital at University of Michigan Medical Center |
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| | Clinical Trials Office - C.S. Mott Children's Hospital | |
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| Minnesota |
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Minneapolis |
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| | Masonic Cancer Center at University of Minnesota |
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| | Clinical Trials Office - Masonic Cancer Center at University of Minnesota | |
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Rochester |
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| | Mayo Clinic Cancer Center |
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| | Clinical Trials Office - All Mayo Clinic Locations | |
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| Mississippi |
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Jackson |
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| | University of Mississippi Cancer Clinic |
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| | Gail Megason | |
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| Missouri |
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Kansas City |
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| | Children's Mercy Hospital |
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| | Maxine Hetherington | |
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St. Louis |
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| | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
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| | Robert Hayashi | |
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| New Jersey |
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Hackensack |
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| | Hackensack University Medical Center Cancer Center |
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| | Clinical Trials Office - Hackensack University Medical Center Cancer Center | |
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| New York |
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New York |
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| | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center |
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| | Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
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| North Carolina |
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Charlotte |
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| | Blumenthal Cancer Center at Carolinas Medical Center |
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| | Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center | |
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| Ohio |
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Cincinnati |
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| | Cincinnati Children's Hospital Medical Center |
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| | Clinical Trials Office - Cincinnati Children's Hospital Medical Center | |
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Cleveland |
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| | Cleveland Clinic Taussig Cancer Center |
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| | Clinical Trials Office - Cleveland Clinic Taussig Cancer Center | |
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| | Rainbow Babies and Children's Hospital |
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| | Yousif (Joe) Matloub | |
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| Oklahoma |
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Oklahoma City |
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| | Oklahoma University Cancer Institute |
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| | Rene McNall-Knapp | |
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| Oregon |
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Portland |
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| | Knight Cancer Institute at Oregon Health and Science University |
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| | Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University | |
| | Email:
trials@ohsu.edu |
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| Pennsylvania |
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Philadelphia |
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| | Children's Hospital of Philadelphia |
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| | Richard Aplenc | |
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Pittsburgh |
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| | Children's Hospital of Pittsburgh |
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| | Clinical Trials Office - Children's Hospital of Pittsburgh | |
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| South Carolina |
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Charleston |
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| | Hollings Cancer Center at Medical University of South Carolina |
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| | Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina | |
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| Tennessee |
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Knoxville |
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| | East Tennessee Children's Hospital |
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| | Ray Pais | |
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Memphis |
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| | St. Jude Children's Research Hospital |
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| | Clinical Trials Office - St. Jude Children's Research Hospital | |
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| Texas |
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Dallas |
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| | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas |
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| | Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | | Ph: | 866-460-4673; 214-648-7097 | | |
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Houston |
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| | Baylor University Medical Center - Houston |
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| | Patrick Thompson | |
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San Antonio |
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| | Methodist Children's Hospital of South Texas |
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| | Michael Grimley | |
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Temple |
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| | CCOP - Scott and White Hospital |
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| | Arlynn Mulne | |
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| Washington |
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Seattle |
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| | Children's Hospital and Regional Medical Center - Seattle |
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| | Julie Park | |
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| Australia |
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| Western Australia |
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Perth |
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| | Princess Margaret Hospital for Children |
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| | Catherine Cole | |
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| Canada |
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| Quebec |
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Montreal |
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| | Hopital Sainte Justine |
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| | Yvan Samson | |
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| | Yvan Samson | |
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