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

NCT00897871 | Unknown

• 4 other identifiers: CCLG-PK-2006-09CDR0000560121EU-20742EUDRACT-2006-002845-36
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 21

Brief 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. PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs work in very young patients with cancer.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

carboplatin DRUG

cyclophosphamide DRUG

etoposide phosphate DRUG

gene expression analysis GENETIC

polymorphism analysis GENETIC

pharmacological study OTHER

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

RECRUITING

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

RECRUITING

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

RECRUITING

University College Hospital

London, England, NW1 2PCE, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

RECRUITING

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

RECRUITING

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

RECRUITING

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

RECRUITING

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

RECRUITING

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

RECRUITING

MeSH Terms

Interventions

Carboplatin; Cyclophosphamide; etoposide phosphate; Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Gareth Veal

  University of Newcastle Upon-Tyne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: February 1, 2007
• Last Updated: August 12, 2013

Record last verified: 2009-06

Locations

IE (1); GB (20)