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
Conditions
Brief 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.
Interventions
OTHERpharmacological study
Correlative studies
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Population PK parameters for dactinomycin and VCR | Not Provided |
| Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition | Not Provided |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children | Not Provided |
| Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR) | Not Provided |
| Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes | Not Provided |
| Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes | Not Provided |
| Pharmacogenetic profiles of patients receiving dactinomycin and VCR | Not Provided |
Countries
Australia, Canada, United States
Outcome results
None listed