Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer
NCT ID: NCT00897871
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
60 participants
OBSERVATIONAL
2007-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs work in very young patients with cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
NCT00003811
Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
NCT00003735
Combination Chemotherapy in Treating Children With Stage III or Stage IV Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
NCT00003217
Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma.
NCT00025597
Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
NCT00024284
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
carboplatin
cyclophosphamide
etoposide phosphate
gene expression analysis
polymorphism analysis
pharmacological study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
2 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gareth Veal
Role: PRINCIPAL_INVESTIGATOR
University of Newcastle Upon-Tyne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
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
University College 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
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
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Contact Person
Role: primary
Contact Person
Role: primary
Amos Burke, MD
Role: primary
Heather P. McDowell, MD
Role: primary
Gill Levitt, MD
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000560121
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20742
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2006-002845-36
Identifier Type: -
Identifier Source: secondary_id
CCLG-PK-2006-09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.