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A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer


N/A
N/A
16 Years
Open (Enrolling)
Both
Kidney Cancer, Leukemia, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

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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 PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Kosair Children's HospitalLouisville, Kentucky  40202-3830
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Midwest Children's Cancer Center at Children's Hospital of WisconsinMilwaukee, Wisconsin  53226
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Childrens Hospital Los AngelesLos Angeles, California  90027
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Keyser Family Cancer Center at Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Connecticut Children's Medical CenterHartford, Connecticut  06106
Nemours Children's Clinic - PensacolaPensacola, Florida  32504