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Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00674193
First received: May 6, 2008
Last updated: February 28, 2012
Last verified: October 2011
History of Changes
  Purpose

RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.

PURPOSE: This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer.


Condition Intervention
Kidney Cancer
Leukemia
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
 Biological: dactinomycin
Drug: vincristine sulfate
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: liquid chromatography
Other: mass spectrometry
Other: pharmacological study

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Population PK parameters for dactinomycin and VCR
  • Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: February 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674193

  Show 57 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Jeffrey M. Skolnik, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00674193     History of Changes
Other Study ID Numbers: CDR0000559243, COG-ADVL06B1
Study First Received: May 6, 2008
Last Updated: February 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Leukemia
Sarcoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Connective and Soft Tissue
 Dactinomycin
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 16, 2013