- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900354
Pharmacokinetics of Dactinomycin in Young Patients With Cancer
Pharmacokinetics of Actinomycin D in Children With Cancer
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Dublin, Ireland, 12
- Recruiting
- Our Lady's Hospital for Sick Children Crumlin
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England
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Birmingham, England, United Kingdom, B4 6NH
- Recruiting
- Birmingham Children's Hospital
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Bristol, England, United Kingdom, BS2 8AE
- Recruiting
- Institute of Child Health at University of Bristol
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Cambridge, England, United Kingdom, CB2 2QQ
- Recruiting
- Addenbrooke's Hospital
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Leeds, England, United Kingdom, LS9 7TF
- Recruiting
- Leeds Cancer Centre at St. James's University Hospital
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Leicester, England, United Kingdom, LE1 5WW
- Recruiting
- Leicester Royal Infirmary
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Contact:
- Mabrouk Madi, MD
- Phone Number: 44-116-258-5959
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Liverpool, England, United Kingdom, L12 2AP
- Recruiting
- Royal Liverpool Children's Hospital, Alder Hey
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London, England, United Kingdom, WC1N 3JH
- Recruiting
- Great Ormond Street Hospital for Children
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Contact:
- Gill Levitt, MD
- Phone Number: 44-20-7405-9200 ext. 0073
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London, England, United Kingdom, W1T 3AA
- Recruiting
- Middlesex Hospital
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Manchester, England, United Kingdom, M27 4HA
- Recruiting
- Royal Manchester Children's Hospital
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Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
- Recruiting
- Sir James Spence Institute of Child Health at Royal Victoria Infirmary
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Newcastle-Upon-Tyne, England, United Kingdom, NE2 4HH
- Recruiting
- University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
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Nottingham, England, United Kingdom, NG7 2UH
- Recruiting
- Queen's Medical Centre
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Oxford, England, United Kingdom, 0X3 9DU
- Recruiting
- Oxford Radcliffe Hospital
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Sheffield, England, United Kingdom, S10 2TH
- Recruiting
- Children's Hospital - Sheffield
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Southampton, England, United Kingdom, SO16 6YD
- Recruiting
- Southampton General Hospital
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Sutton, England, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden - Surrey
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT12 6BE
- Recruiting
- Royal Belfast Hospital for Sick Children
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Scotland
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Aberdeen, Scotland, United Kingdom, AB25 2ZG
- Recruiting
- Royal Aberdeen Children's Hospital
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Edinburgh, Scotland, United Kingdom, EH9 1LF
- Recruiting
- Royal Hospital for Sick Children
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Glasgow, Scotland, United Kingdom, G3 8SJ
- Recruiting
- Royal Hospital for Sick Children
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Wales
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Cardiff, Wales, United Kingdom, CF14 4XW
- Recruiting
- Childrens Hospital for Wales
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- 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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetics (PKs) of dactinomycin
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Degree of interpatient variation of drug PKs
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Influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs
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Correlation of drug PKs with clinical response and toxicity, particularly the incidence of severe liver toxicity or veno-occlusive disease
|
Collaborators and Investigators
Investigators
- Study Chair: Gareth Veal, University of Newcastle Upon-Tyne
- Alan Boddy, PhD, University of Newcastle Upon-Tyne
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CCLG-PK-2006-07
- CDR0000531136 (Registry Identifier: PDQ (Physician Data Query))
- EUDRACT-2005-002996-34
- EU-20643
- CCLG-CTA-21275/0218/001-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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