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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| | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham |
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| | Clinical Trials Office - Lurleen Wallace Comprehensive Cancer | |
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| California |
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Long Beach |
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| | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital |
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| | Jerry Finklestein | |
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Los Angeles |
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| | Jonsson Comprehensive Cancer Center at UCLA |
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| | Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA | |
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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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| District of Columbia |
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Washington |
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| | Children's National Medical Center |
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| | Clinical Trials Office - Children's National Medical Center | |
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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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| 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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| | David Walterhouse | |
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| Indiana |
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Indianapolis |
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|
| | Indiana University Melvin and Bren Simon Cancer Center |
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| | Clinical Trials Office - Indiana University Cancer Center | |
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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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| Massachusetts |
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Boston |
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| | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
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| | Holcombe Grier | |
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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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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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Asheville |
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| | Mission Hospitals - Memorial Campus |
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| | Clinical Trials Office - Mission Hospitals - Memorial Campus | |
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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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| 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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| | Oregon Health and Science University Cancer Institute |
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| | Clinical Trials Office - Oregon Health and Science University Cancer Institute | |
| | Email:
trials@ohsu.edu |
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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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| | Alberto Pappo | |
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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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| | Douglas Hawkins | |
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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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| Ontario |
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Toronto |
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| | Hospital for Sick Children |
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| | Ronald Grant | |
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Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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