Skip to main content
OpenTrials
Completed

NCT Number: NCT00674193

Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Childhood Acute Lymphoblastic Leukemia Childhood Rhabdomyosarcoma Childhood Soft Tissue Sarcoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ewing Sarcoma Ewing Sarcoma of Bone Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Osteosarcoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Sarcoma Sarcoma, Ewing Unspecified Childhood Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilms Tumor Wilms Tumor and Other Childhood Kidney Tumors

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacological study

Other

Correlative studies

Other names: pharmacological studies

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Population PK parameters for dactinomycin and VCR

    Time frame: Not Provided

  2. Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition

    Time frame: Not Provided

Secondary outcomes

  1. Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)

    Time frame: Not Provided

  2. Pharmacogenetic profiles of patients receiving dactinomycin and VCR

    Time frame: Not Provided

  3. Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children

    Time frame: Not Provided

  4. Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes

    Time frame: Not Provided

  5. Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes

    Time frame: Not Provided

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
First posted
May 7, 2008
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.