Spots Global Cancer Trial Database for Pharmacokinetics of Dactinomycin in Young Patients With Cancer
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Trial Identification
Brief Title: Pharmacokinetics of Dactinomycin in Young Patients With Cancer
Official Title: Pharmacokinetics of Actinomycin D in Children With Cancer
Study ID: NCT00900354
Study Description
Brief Summary: RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving dactinomycin may help doctors learn how dactinomycin works in the body and how patients will respond to treatment. PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young patients with cancer.
Detailed Description: OBJECTIVES: * Determine the pharmacokinetics (PKs) of dactinomycin in pediatric patients with cancer. * Determine the degree of interpatient variation in the PKs of this drug. * Determine the influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs in these patients. * Correlate drug PKs with clinical response and toxicity observed in these patients, focusing particularly on the incidence of severe liver toxicity or veno-occlusive disease. * Correlate pharmacogenetic variability with clinical and PK data. OUTLINE: This is a multicenter study. Patients undergo blood collection for pharmacokinetic sampling of dactinomycin at baseline (prior to the initiation of dactinomycin) and periodically during course 1 of chemotherapy. An additional blood sample is obtained before or after treatment for the collection of peripheral blood lymphocytes. DNA from these cells is isolated and investigated for genetic variation in genes relevant to the pharmacology of dactinomycin. Plasma concentrations of dactinomycin are determined by liquid chromatography mass spectrometry analysis. Patients are followed for 2 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Our Lady's Hospital for Sick Children Crumlin, Dublin, , Ireland
Birmingham Children's Hospital, Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol, 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
Middlesex 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
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research, 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: STUDY_CHAIR
Name: Alan Boddy, PhD
Affiliation: University of Newcastle Upon-Tyne
Role:
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