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Last Modified: 11/21/2009     First Published: 8/3/2007  
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Study of the Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics of Dactinomycin and Vincristine in Pediatric Patients With Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, TreatmentActiveUnder 17NCICOG-ADVL06B1
ADVL06B1, NCT00674193

Objectives

Primary

  1. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.
  2. To identify demographic or physiological factors that are determinants of dactinomycin disposition.
  3. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.
  4. To identify demographic or physiological factors that are determinants of VCR disposition.

Secondary

  1. To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.
  2. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer.

Entry 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

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • Other concurrent chemotherapeutic agents allowed

Patient Characteristics:

  • Able to comply with study requirements

Expected Enrollment

260

Outcomes

Primary Outcome(s)

Population PK parameters for dactinomycin and VCR
Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition

Secondary Outcome(s)

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

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Jeffrey Skolnik, MD, Protocol chair
Ph: 215-590-6359

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Clinical Trials Office - UAB Comprehensive Cancer Center
Ph: 205-934-0309
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
California
  Los Angeles
 Childrens Hospital Los Angeles
 Leo Mascarenhas
Ph: 323-361-2529
  Orange
 Children's Hospital of Orange County
 Violet Shen
Ph: 714-532-8636
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
Delaware
  Wilmington
 Alfred I. duPont Hospital for Children
 Clinical Trials Office - Alfred I. duPont Hospital for Children
Ph: 302-651-5755
Florida
  Jacksonville
 Nemours Children's Clinic
 Eric Sandler
Ph: 904-697-3793
  Tampa
 St. Joseph's Cancer Institute at St. Joseph's Hospital
 Clinical Trials Office - St. Joseph's Cancer Institute
Ph: 800-882-4123
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Howard Katzenstein
Ph: 404-785-0853
Illinois
  Chicago
 Children's Memorial Hospital - Chicago
 Stewart Goldman
Ph: 773-880-3270
  Oak Lawn
 Advocate Christ Medical Center
 Sharad Salvi
Ph: 708-684-4094
Indiana
  Indianapolis
 St. Vincent Indianapolis Hospital
 Clinical Trials Office - St. Vincent Indianapolis Hospital
Ph: 317-338-2194
Kentucky
  Lexington
 Lucille P. Markey Cancer Center at University of Kentucky
 Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center
Ph: 859-257-3379
  Louisville
 Kosair Children's Hospital
 Clinical Trials Office - Kosair Children's Hospital
Ph: 502-629-5500
 Email: CancerResource@nortonhealthcare.org
Michigan
  Ann Arbor
 C.S. Mott Children's Hospital at University of Michigan Medical Center
 Clinical Trials Office - C.S. Mott Children's Hospital
Ph: 1-800-865-1125
Minnesota
  Minneapolis
 Masonic Cancer Center at University of Minnesota
 Clinical Trials Office - Masonic Cancer Center at University of Minnesota
Ph: 612-624-2620
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail Megason
Ph: 601-984-5220
Missouri
  Kansas City
 Children's Mercy Hospital
 Maxine Hetherington
Ph: 816-234-3265
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Robert Hayashi
Ph: 314-454-4118
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Clinical Trials Office - Hackensack University Medical Center Cancer Center
Ph: 201-996-2879
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Ph: 212-305-8615
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884
Ohio
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 Clinical Trials Office - Cincinnati Children's Hospital Medical Center
Ph: 513-636-2799
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
 Rainbow Babies and Children's Hospital
 Yousif (Joe) Matloub
Ph: 216-844-3345
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Rene McNall-Knapp
Ph: 405-271-5311
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University
Ph: 503-494-1080
 Email: trials@ohsu.edu
Pennsylvania
  Philadelphia
 Children's Hospital of Philadelphia
 Richard Aplenc
Ph: 267-426-7252
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina
Ph: 843-792-9321
Tennessee
  Knoxville
 East Tennessee Children's Hospital
 Ray Pais
Ph: 865-541-8266
  Memphis
 St. Jude Children's Research Hospital
 Clinical Trials Office - St. Jude Children's Research Hospital
Ph: 901-595-4644
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Ph: 866-460-4673; 214-648-7097
  Houston
 Baylor University Medical Center - Houston
 Patrick Thompson
Ph: 832-824-4029
  San Antonio
 Methodist Children's Hospital of South Texas
 Michael Grimley
Ph: 210-575-7268
  Temple
 CCOP - Scott and White Hospital
 Arlynn Mulne
Ph: 254-724-2006
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Julie Park
Ph: 206-987-2106
Australia
Western Australia
  Perth
 Princess Margaret Hospital for Children
 Catherine Cole
Ph: 011-6189340-8238
Canada
Quebec
  Montreal
 Hopital Sainte Justine
 Yvan Samson
Ph: 418-656-4141x47191
 Yvan Samson
Ph: 514-345-4969

Registry Information
Official Title A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children with Cancer
Trial Start Date 2008-02-11
Registered in ClinicalTrials.gov NCT00674193
Date Submitted to PDQ 2007-07-05
Information Last Verified 2009-11-23
NCI Grant/Contract Number CA98543

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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