Pharmacokinetic Study of Doxorubicin in Children With Cancer
NCT ID: NCT01095926
Last Updated: 2013-06-28
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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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2010-05-31
2013-05-31
Brief Summary
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Detailed Description
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* PK samples will be collected from two doxorubicin administrations. Analyzing samples from two doxorubicin administrations will allow distinguishing between interindividual, intraindividual and residual variability.
* Doxorubicin and its major metabolite doxorubicinol will be measured in plasma using HPLC
* In addition, the natriuretic peptide BNP and the precursors NT-pro ANP and NT-proBNP as well as troponin T will be measured in plasma up to 28 days after doxorubicin administration to evaluate their use as clinical markers for cardiotoxicity.
* A data set of max 5 samples (3 +2 (in the 1st + 2nd Doxorubicin sampling periods)) will be collected in the younger children (\< 3 years) and a data set of max. 8 samples ( 5 + 3) will be collected in the older children. Samples will be taken at predefined time points/ time intervals.
* An additional DNA sample will be taken and analyzed for genetic polymorphisms. The influence of genotype on pharmacokinetics and metabolism will be investigated by appropriate statistical methods, including population pharmacokinetic analyses. Genes to study would include MDR1 and SLC22A16, both involved in the transport of doxorubicin and AKR1A1 and CBR1, both involved in the reduction of doxorubicin to doxorubicinol. Selected genotypes will be incorporated as covariates into the population pharmacokinetic models developed. The potential impact of genetic variation will be evaluated in the context of other sources of variability such as age, weight, gender etc
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Doxorubicin
doxorubicin
blood sampling before, during and after doxorubicin administration
Interventions
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doxorubicin
blood sampling before, during and after doxorubicin administration
Eligibility Criteria
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Inclusion Criteria
* plan to receive at least two cycles of doxorubicin
* must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol Or Patients \< 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
* Parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
* Life expectancy of at least 3 month
* Karnofsky performance status of ≥ 70%
* Additional blood withdrawal is acceptable for the patient. The decision is left to the investigator
Exclusion Criteria
17 Years
ALL
No
Sponsors
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University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Joachim Boos, MD, Prof.
Role: STUDY_CHAIR
University Hospital Muenster
Locations
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Centre Oscar Lambret
Lille, , France
CHU La Timone
Marseille, , France
MD Nicolas Andre, National Study Manager France
Marseille, , France
CHU Nancy
Nancy, , France
CHU Nantes
Nantes, , France
Institut curie
Paris, , France
Institut Gustanve Roussy
Paris, , France
Universitätsklinikum Essen
Essen, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Kiel
Kiel, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Stuttgart
Stuttgart, , Germany
Prof. Maurizio D'Incalci, National Study Manager Italy
Milan, , Italy
Università degli Studi di Milano
Monza, , Italy
Clinica di Oncoematologia Pediatrica
Padua, , Italy
Università Cattolica di Roma
Rome, , Italy
Birmingham Childrens Hospital
Birmingham, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Royal Manchester Childrens Hospital
Manchester, , United Kingdom
Prof. Alan Boddy, National Study Manager UK
Newcastle upon Tyne, , United Kingdom
Royal Victoria Infirmary, Sir James Spence Institute of Child Health
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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2009-011454-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EPOC-MS-001
Identifier Type: -
Identifier Source: org_study_id