Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer
- Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00897871
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on event-free survival Pharmacokinetic modelling comparing pharmacokinetic parameters to investigate the key factors involved in determining individual exposures to parent drugs and metabolites Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Bristol Royal Hospital for Children
🇬🇧Bristol, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, Scotland, United Kingdom
Childrens Hospital for Wales
🇬🇧Cardiff, Wales, United Kingdom