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Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00674193
First Posted: May 7, 2008
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. 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.

Condition Intervention
Childhood Acute Lymphoblastic Leukemia Childhood Rhabdomyosarcoma Childhood Soft Tissue Sarcoma Ewing Sarcoma Ewing Sarcoma of Bone Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) Unspecified Childhood Solid Tumor, Protocol Specific Wilms Tumor and Other Childhood Kidney Tumors Other: pharmacological study Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Population PK parameters for dactinomycin and VCR [ Time Frame: Not Provided ]
  • Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition [ Time Frame: Not Provided ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR) [ Time Frame: Not Provided ]
  • Pharmacogenetic profiles of patients receiving dactinomycin and VCR [ Time Frame: Not Provided ]
  • Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children [ Time Frame: Not Provided ]
  • Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes [ Time Frame: Not Provided ]
  • Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes [ Time Frame: Not Provided ]

Biospecimen Retention:   Samples With DNA
blood and urine

Enrollment: 158
Study Start Date: February 2008
Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (pharmacological 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.
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.

II. To identify demographic or physiological factors that are determinants of dactinomycin disposition.

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

IV. To identify demographic or physiological factors that are determinants of VCR disposition.

SECONDARY OBJECTIVES:

I. To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.

II. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of cancer, including, but not limited to, any of the following: Acute lymphoblastic leukemia, Ewing sarcoma, Rhabdomyosarcoma, Soft tissue sarcoma, Wilms tumor who are due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
Criteria

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
  • Other concurrent chemotherapeutic agents allowed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674193


  Show 38 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey Skolnik Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00674193     History of Changes
Other Study ID Numbers: ADVL06B1
NCI-2009-00362 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ADVL06B1 ( Other Identifier: Children's Oncology Group )
CDR0000559243 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2008
First Posted: May 7, 2008
Last Update Posted: May 17, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Sarcoma, Ewing
Sarcoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Rhabdomyosarcoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Wilms Tumor
Rhabdomyosarcoma, Embryonal
Neuroectodermal Tumors, Primitive, Peripheral
Kidney Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Leukemia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myosarcoma
Neoplasms, Muscle Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Neoplasms, Complex and Mixed
Urologic Neoplasms