NCT00897871

Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer

Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cyclophosphamide
DRUG	etoposide phosphate
GENETIC	gene expression analysis
GENETIC	polymorphism analysis
OTHER	pharmacological study

Timeline

• Start date: 2007-02-01
• First posted: 2009-05-12
• Last updated: 2013-08-12

Locations

21 sites across 2 countries: Ireland, United Kingdom