Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897871
First received: May 9, 2009
Last updated: August 9, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide phosphate
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: pharmacological study

Study Type: Observational
Official Title: Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Designated as safety issue: No ]
  • Pharmacokinetic modelling comparing pharmacokinetic parameters to investigate the key factors involved in determining individual exposures to parent drugs and metabolites [ Designated as safety issue: No ]
  • Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on event-free survival [ Designated as safety issue: No ]
  • Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on toxicity [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897871

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Contact Person    353-1-409-6659      
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, England, United Kingdom, B4 6NH
Contact: Martin W. English, MD    44-121-333-8412    martin.english@bch.nhs.uk   
Bristol Royal Hospital for Children Recruiting
Bristol, England, United Kingdom, BS2 8BJ
Contact: Contact Person    44-117-342-0205      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Amos Burke, MD    44-1223-348-151      
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Adam Glaser, MD    44-113-206-4984    adam.glaser@leedsth.nhs.uk   
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Johann Visser, MD    44-116-258-5309    johannes.visser@uhl-tr.nhs.uk   
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD    44-151-293-3679      
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Gill Levitt, MD    44-20-7405-9200 ext. 0073      
University College Hospital Recruiting
London, England, United Kingdom, NW1 2PCE
Contact: Maria Michelagnoli, MD    44-20-7380-9064    maria.michelagnoli@uclh.nhs.uk   
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD    44-161-922-2227    bernadette.brennan@cmmc.nhs.uk   
Sir James Spence Institute of Child Health at Royal Victoria Infirmary Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Juliet Hale, MD    44-191-282-4101    j.p.hale@ncl.ac.uk   
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH    44-115-924-9924 ext. 63394    martin.hewitt@nuh.nhs.uk   
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Kate Wheeler, MD    44-186-522-1066      
Children's Hospital - Sheffield Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH    44-114-271-7366    mary.gerrard@sch.nhs.uk   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP    44-23-8079-6942      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary Taj, MD    44-20-8642-6011 ext. 3089      
Royal Belfast Hospital for Sick Children Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Contact: Anthony McCarthy, MD    44-289-063-3631    anthonymcarthy@royalhospital.n.i.nhs.uk   
Royal Aberdeen Children's Hospital Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Contact: Veronica Neefjes    44-1224-550-217      
Royal Hospital for Sick Children Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD    44-141-201-9309      
Childrens Hospital for Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Heidi Traunecker, MD, PhD    44-29-2074-2285    heidi.traunecker@cardiffandvale.wales.nhs.uk   
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Principal Investigator: Gareth Veal University of Newcastle Upon-Tyne
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00897871     History of Changes
Other Study ID Numbers: CCLG-PK-2006-09, CDR0000560121, EU-20742, EUDRACT-2006-002845-36
Study First Received: May 9, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Cyclophosphamide
Etoposide phosphate
Etoposide
Carboplatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 20, 2014