Pharmacokinetics of Dactinomycin in Young Patients With Cancer
NCT ID: NCT00900354
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2006-06-30
Brief Summary
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PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young patients with cancer.
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Detailed Description
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* 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.
Conditions
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Interventions
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molecular genetic technique
mass spectrometry
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cancer
* Currently being treated with dactinomycin on a clinical trial at a United Kingdom Children's Cancer Study Group center
PATIENT CHARACTERISTICS:
* Single- or double-lumen central venous catheter or portacath in place
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
21 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Gareth Veal
Role: STUDY_CHAIR
University of Newcastle Upon-Tyne
Alan Boddy, PhD
Role:
University of Newcastle Upon-Tyne
Locations
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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
Countries
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Facility Contacts
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Pamela Kearns, MD
Role: primary
Amos Burke, MD
Role: primary
Mabrouk Madi, MD
Role: primary
Heather P. McDowell, MD
Role: primary
Ananth Shankar, MD
Role: primary
Gill Levitt, MD
Role: primary
Gareth Veal
Role: primary
Kate Wheeler, MD
Role: primary
Janice A. Kohler, MD, FRCP
Role: primary
Mary Taj, MD
Role: primary
Veronica Neefjes
Role: primary
W. Hamish Wallace, MD
Role: primary
Milind D. Ronghe, MD
Role: primary
References
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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.
Other Identifiers
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CDR0000531136
Identifier Type: REGISTRY
Identifier Source: secondary_id
EUDRACT-2005-002996-34
Identifier Type: -
Identifier Source: secondary_id
EU-20643
Identifier Type: -
Identifier Source: secondary_id
CCLG-CTA-21275/0218/001-0001
Identifier Type: -
Identifier Source: secondary_id
CCLG-PK-2006-07
Identifier Type: -
Identifier Source: org_study_id
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