A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
N/A
16 Years
Both
Kidney Cancer, Leukemia, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
OBJECTIVES:
Primary
- To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and
adolescents with cancer.
- To identify demographic or physiological factors that are determinants of dactinomycin
disposition.
- To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with
cancer.
- To identify demographic or physiological factors that are determinants of VCR
disposition.
Secondary
- To examine the correlation of dactinomycin and VCR systemic exposure metrics with
toxicity outcomes.
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- Able to comply with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Other concurrent chemotherapeutic agents allowed
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Population PK parameters for dactinomycin and VCR
Principal Investigator
Jeffrey M. Skolnik, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Children's Hospital of Philadelphia
Authority:
United States: Federal Government
Study ID:
CDR0000559243
NCT ID:
NCT00674193
Start Date:
February 2008
Completion Date:
Related Keywords:
- Kidney Cancer
- Leukemia
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
- Ewing sarcoma of bone
- Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Ewing sarcoma
- Wilms tumor and other childhood kidney tumors
- childhood acute lymphoblastic leukemia
- childhood rhabdomyosarcoma
- childhood soft tissue sarcoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Leukemia
- Sarcoma
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
| Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
| East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53226 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
| Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
| St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
| Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
| Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
| Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
| Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
| Childrens Hospital Los Angeles | Los Angeles, California 90027 |
| Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
| UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
| Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
