Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00674193
First received: May 6, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]
  • Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition [ Time Frame: Not Provided ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR) [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Pharmacogenetic profiles of patients receiving dactinomycin and VCR [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes [ Time Frame: Not Provided ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood and urine


Enrollment: 158
Study Start Date: February 2008
Estimated Primary Completion Date: January 2100 (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

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674193

  Show 38 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Jeffrey Skolnik Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00674193     History of Changes
Other Study ID Numbers: ADVL06B1, NCI-2009-00362, COG-ADVL06B1, CDR0000559243, U10CA098543
Study First Received: May 6, 2008
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcoma, Ewing
Sarcoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Wilms Tumor
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Kidney Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Leukemia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Complex and Mixed
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn
Osteosarcoma

ClinicalTrials.gov processed this record on September 30, 2014