Unspecified Childhood Solid Tumor, Protocol SpecificNCT00897871
Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer
An observational study of Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- carboplatin, cyclophosphamide and etoposide phosphate
- How many people
- 60 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Feb 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Diagnosis of childhood cancer
- Receiving carboplatin, cyclophosphamide, or etoposide as standard treatment as part of a clinical study at a Children's Cancer and Leukemia Group (CCLG) center
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Single or double lumen central venous catheter in place
- No concurrent anticonvulsants, azole antifungal agents, or chronic steroid treatment
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United Kingdom20 sites, 20 recruiting
- Recruiting
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Veronica Neefjes, 44-1224-550-217
- Recruiting
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Anthony McCarthy, MD, 44-289-063-3631, anthonymcarthy@royalhospital.n.i.nhs.uk
- Recruiting
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Martin W. English, MD, 44-121-333-8412, martin.english@bch.nhs.uk
- Recruiting
Bristol Royal Hospital for Children
Bristol, England, BS2 8BJ
Contact Person, 44-117-342-0205
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Amos Burke, MD, 44-1223-348-151
- Recruiting
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Heidi Traunecker, MD, PhD, 44-29-2074-2285, heidi.traunecker@cardiffandvale.wales.nhs.uk
- Recruiting
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
W. Hamish Wallace, MD, 44-131-536-0426
- Recruiting
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Milind D. Ronghe, MD, 44-141-201-9309
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Adam Glaser, MD, 44-113-206-4984, adam.glaser@leedsth.nhs.uk
- Recruiting
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Johann Visser, MD, 44-116-258-5309, johannes.visser@uhl-tr.nhs.uk
- Recruiting
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Heather P. McDowell, MD, 44-151-293-3679
- Recruiting
University College Hospital
London, England, NW1 2PCE
Maria Michelagnoli, MD, 44-20-7380-9064, maria.michelagnoli@uclh.nhs.uk
- Recruiting
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Gill Levitt, MD, 44-20-7405-9200 ext. 0073
- Recruiting
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Bernadette Brennan, MD, 44-161-922-2227, bernadette.brennan@cmmc.nhs.uk
- Recruiting
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Juliet Hale, MD, 44-191-282-4101, j.p.hale@ncl.ac.uk
- Recruiting
Queen's Medical Centre
Nottingham, England, NG7 2UH
Martin Hewitt, MD, BSc, FRCP, FRCPCH, 44-115-924-9924 ext. 63394, martin.hewitt@nuh.nhs.uk
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Kate Wheeler, MD, 44-186-522-1066
- Recruiting
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Mary P. Gerrard, MBChB, FRCP, FRCPCH, 44-114-271-7366, mary.gerrard@sch.nhs.uk
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Janice A. Kohler, MD, FRCP, 44-23-8079-6942
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Mary Taj, MD, 44-20-8642-6011 ext. 3089
Ireland1 site, 1 recruiting
- Recruiting
Our Lady's Hospital for Sick Children Crumlin
Dublin, 12
Contact Person, 353-1-409-6659
About this study
Official title: Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children
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.
Read the detailed description
OBJECTIVES:
- Investigate inter-individual variability in the pharmacokinetics of selected anticancer drugs in infants and children age < 2 years on current dosing schedules.
- Compare drug exposures and degree of pharmacokinetic variability in children < 2 years with data obtained from published studies in older children.
- Relate inter-individual variability in pharmacokinetics and drug exposure to clinical toxicity and response.
- Use pharmacokinetic data in conjunction with clinical information obtained following treatment to investigate the suitability of current dosing regimens in infants and young children.
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.
- Being tested
- carboplatin, cyclophosphamide, etoposide phosphate, gene expression analysis, polymorphism analysis
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cyclophosphamideDrug
etoposide phosphateDrug
gene expression analysisGenetic
polymorphism analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Gareth Veal, Principal investigator, University of Newcastle Upon-Tyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897871
- Sponsor's protocol ID
- CCLG-PK-2006-09
- Other IDs
- CDR0000560121, EU-20742, EUDRACT-2006-002845-36
- Status last verified
- Jun 2009
- First submitted
- 9 May 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children
- ClinicalTrials.gov ID
- NCT00897871
- Acronym / sponsor ID
- CCLG-PK-2006-09
- Keywords
- unspecified childhood solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Feb 2007
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Investigate inter-individual variability in the pharmacokinetics of selected anticancer drugs in infants and children age < 2 years on current dosing schedules.
- Compare drug exposures and degree of pharmacokinetic variability in children < 2 years with data obtained from published studies in older children.
- Relate inter-individual variability in pharmacokinetics and drug exposure to clinical toxicity and response.
- Use pharmacokinetic data in conjunction with clinical information obtained following treatment to investigate the suitability of current dosing regimens in infants and young children.
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.
Study design
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| etoposide phosphate | Drug | – |
| gene expression analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| pharmacological study | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth Veal principal investigator
University of Newcastle Upon-Tyne
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.