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

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

Official title:

Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00897871
• Other study ID #: CCLG-PK-2006-09
• Secondary ID: CDR0000560121EU-
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 9, 2013
• Start date: February 2007

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• carboplatin

• cyclophosphamide

• etoposide phosphate

Genetic:
• gene expression analysis

• polymorphism analysis

Other:
• pharmacological study

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children Crumlin	Dublin
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Bristol Royal Hospital for Children	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Childrens Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
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	Great Ormond Street Hospital for Children	London	England
United Kingdom	University College Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters			No
Primary	Pharmacokinetic modelling comparing pharmacokinetic parameters to investigate the key factors involved in determining individual exposures to parent drugs and metabolites			No
Primary	Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on event-free survival			No
Primary	Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on toxicity			No