Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children
N/A
2 Years
Both
Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Pharmacokinetic parameters
Safety Issue:
No
Principal Investigator
Gareth Veal
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Newcastle Upon-Tyne
Authority:
Unspecified
Study ID:
CDR0000560121
NCT ID:
NCT00897871
Start Date:
February 2007
Completion Date:
Related Keywords:
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
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