Know Cancer

forgot password

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

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

Thank you

Trial Information

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



- 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

- To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with

- To identify demographic or physiological factors that are determinants of VCR


- 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

Inclusion Criteria


- 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


- See Disease Characteristics

- Other concurrent chemotherapeutic agents allowed

Type of Study:


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


United States: Federal Government

Study ID:




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



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