NCT00674193

Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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.

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

Interventions

Type	Name	Description
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2008-02-01
• Primary completion: 2016-06-30
• First posted: 2008-05-07
• Last updated: 2017-05-17

Locations

38 sites across 3 countries: United States, Australia, Canada