Pharmacokinetics of Dactinomycin in Young Patients With Cancer
Pharmacokinetics of Actinomycin D in Children With Cancer
5 other identifiers
observational
50
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedAugust 12, 2013
June 1, 2009
May 9, 2009
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pharmacokinetics (PKs) of dactinomycin
Degree of interpatient variation of drug PKs
Influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs
Correlation of drug PKs with clinical response and toxicity, particularly the incidence of severe liver toxicity or veno-occlusive disease
Interventions
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (22)
Our Lady's Hospital for Sick Children Crumlin
Dublin, 12, Ireland
Birmingham Children's Hospital
Birmingham, England, B4 6NH, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE, United Kingdom
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester, England, LE1 5WW, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP, United Kingdom
Middlesex Hospital
London, England, W1T 3AA, United Kingdom
Great Ormond Street Hospital for Children
London, England, WC1N 3JH, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, M27 4HA, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP, United Kingdom
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, England, NE2 4HH, United Kingdom
Queen's Medical Centre
Nottingham, England, NG7 2UH, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, S10 2TH, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
Royal Marsden - Surrey
Sutton, England, SM2 5PT, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Related Publications (1)
Kim HY, Veal GJ, Zhou F, Boddy AV. The role of solute carrier (SLC) transporters in actinomycin D pharmacokinetics in paediatric cancer patients. Eur J Clin Pharmacol. 2018 Dec;74(12):1575-1584. doi: 10.1007/s00228-018-2544-z. Epub 2018 Aug 30.
PMID: 30167756DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gareth Veal
University of Newcastle Upon-Tyne
Alan Boddy, PhD
University of Newcastle Upon-Tyne