Spots Global Cancer Trial Database for Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer
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Trial Identification
Brief Title: Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer
Official Title: Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children
Study ID: NCT00897871
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Our Lady's Hospital for Sick Children Crumlin, Dublin, , Ireland
Birmingham Children's Hospital, Birmingham, England, United Kingdom
Bristol Royal Hospital for Children, Bristol, England, United Kingdom
Addenbrooke's Hospital, Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey, Liverpool, England, United Kingdom
University College Hospital, London, England, United Kingdom
Great Ormond Street Hospital for Children, London, England, United Kingdom
Royal Manchester Children's Hospital, Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary, Newcastle-Upon-Tyne, England, United Kingdom
Queen's Medical Centre, Nottingham, England, United Kingdom
Oxford Radcliffe Hospital, Oxford, England, United Kingdom
Children's Hospital - Sheffield, Sheffield, 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
Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales, Cardiff, Wales, United Kingdom
Contact Details
Name: Gareth Veal
Affiliation: University of Newcastle Upon-Tyne
Role: PRINCIPAL_INVESTIGATOR
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