Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children 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.
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.
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