Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children
RATIONALE: Studying samples of blood in the laboratory from young patients with cancer may
help doctors learn how carboplatin, cyclophosphamide, and etoposide affect the body and how
patients will respond to treatment.
PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs
work in very young patients with cancer.
OBJECTIVES:
- Investigate inter-individual variability in the pharmacokinetics of selected anticancer
drugs in infants and children age < 2 years on current dosing schedules.
- Compare drug exposures and degree of pharmacokinetic variability in children < 2 years
with data obtained from published studies in older children.
- Relate inter-individual variability in pharmacokinetics and drug exposure to clinical
toxicity and response.
- Use pharmacokinetic data in conjunction with clinical information obtained following
treatment to investigate the suitability of current dosing regimens in infants and
young children.
OUTLINE: This is a multicenter study. Patients are stratified according to age in months (0
to 6 vs 6 to 12 vs 12 to 24).
Patients receive carboplatin, cyclophosphamide, or etoposide according to the dosing regimen
detailed in the clinical protocol on which the child is being treated.
Blood samples are collected from patients receiving 1 of the 3 drugs by central venous
catheter periodically during treatment to measure pharmacokinetics of the specific drug.
Additional blood samples are collected for DNA extraction and polymorphism analysis in
CYP2B6, CYP2C9, and other metabolizing enzymes in addition to the determination of the
genetic variation in multiple drug resistance.
;
N/A
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