Overview

This trial is active, not recruiting.

Conditions 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
Treatments pharmacological study, laboratory biomarker analysis
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2008
End date January 2100
Trial size 158 participants
Trial identifier NCT00674193, ADVL06B1, CDR0000559243, COG-ADVL06B1, NCI-2009-00362, U10CA098543

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
pharmacological study pharmacological studies
Correlative studies
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants up to 16 years old.

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

Additional Information

Official title A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
Principal investigator Jeffrey Skolnik
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Children's Oncology Group.