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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000560121 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20742 | |||
| EUDRACT-2006-002845-36 |
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RATIONALE: Studying samples of blood in the laboratory from young patients with cancer may help doctors learn how carboplatin, cyclophosphamide, and etoposide affect the body and how patients will respond to treatment.
PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs work in very young patients with cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to age in months (0 to 6 vs 6 to 12 vs 12 to 24).
Patients receive carboplatin, cyclophosphamide, or etoposide according to the dosing regimen detailed in the clinical protocol on which the child is being treated.
Blood samples are collected from patients receiving 1 of the 3 drugs by central venous catheter periodically during treatment to measure pharmacokinetics of the specific drug. Additional blood samples are collected for DNA extraction and polymorphism analysis in CYP2B6, CYP2C9, and other metabolizing enzymes in addition to the determination of the genetic variation in multiple drug resistance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cyclophosphamide | Drug | |||
| etoposide phosphate | Drug | |||
| gene expression analysis | Genetic | |||
| polymorphism analysis | Genetic | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | ||
| Pharmacokinetic modelling comparing pharmacokinetic parameters to investigate the key factors involved in determining individual exposures to parent drugs and metabolites | ||
| Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on event-free survival | ||
| Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on toxicity |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Gareth Veal | University of Newcastle Upon-Tyne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children Crumlin | Recruiting | Dublin | 12 | Ireland |
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| Birmingham Children's Hospital | Recruiting | Birmingham | England | B4 6NH | United Kingdom |
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| Bristol Royal Hospital for Children | Recruiting | Bristol | England | BS2 8BJ | United Kingdom |
|
| Addenbrooke's Hospital | Recruiting | Cambridge | England | CB2 2QQ | United Kingdom |
|
| Leeds Cancer Centre at St. James's University Hospital | Recruiting | Leeds | England | LS9 7TF | United Kingdom |
|
| Leicester Royal Infirmary | Recruiting | Leicester | England | LE1 5WW | United Kingdom |
|
| Royal Liverpool Children's Hospital, Alder Hey | Recruiting | Liverpool | England | L12 2AP | United Kingdom |
|
| University College Hospital | Recruiting | London | England | NW1 2PCE | United Kingdom |
|
| Great Ormond Street Hospital for Children | Recruiting | London | England | WC1N 3JH | United Kingdom |
|
| Royal Manchester Children's Hospital | Recruiting | Manchester | England | M27 4HA | United Kingdom |
|
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Recruiting | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
|
| Queen's Medical Centre | Recruiting | Nottingham | England | NG7 2UH | United Kingdom |
|
| Oxford Radcliffe Hospital | Recruiting | Oxford | England | 0X3 9DU | United Kingdom |
|
| Children's Hospital - Sheffield | Recruiting | Sheffield | England | S10 2TH | United Kingdom |
|
| Southampton General Hospital | Recruiting | Southampton | England | SO16 6YD | United Kingdom |
|
| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
|
| Royal Belfast Hospital for Sick Children | Recruiting | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
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| Royal Aberdeen Children's Hospital | Recruiting | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
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| Royal Hospital for Sick Children | Recruiting | Edinburgh | Scotland | EH9 1LF | United Kingdom |
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| Royal Hospital for Sick Children | Recruiting | Glasgow | Scotland | G3 8SJ | United Kingdom |
|
| Childrens Hospital for Wales | Recruiting | Cardiff | Wales | CF14 4XW | United Kingdom |
|
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| C061400 | etoposide phosphate |
| D020869 | Gene Expression Profiling |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016172 | DNA Fingerprinting |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
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