Pharmacokinetics of chemotherapeutic agents in children’s oncology
Recruiting
- Conditions
- Cancer
- Registration Number
- NL-OMON25390
- Lead Sponsor
- Princess Maxima Center for pediatric oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 270
Inclusion Criteria
1.Planned to receive carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, doxorubicin, etoposide, methotrexate or vincristine intravenously as regular treatment (standard of care);
2.Age =18 years;
3.Informed consent form (ICF) signed prior to participation in the study;
4.A present central line to sample blood for pharmacokinetics
Exclusion Criteria
1.Down syndrome;
2.For fertile adolescent girls: pregnancy (orally inquired, a test is not necessary);
3.Any other disease/circumstances that may influence the participation of the subject in a negative way
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the pharmacokinetics of various cytotoxic agents (carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, doxorubicin, etoposide, methotrexate and vincristine) and their known metabolites (if applicable) in children to characterize the age-related changes in pharmacokinetics.
- Secondary Outcome Measures
Name Time Method -To determine the influence of overweight and obesitas (for cut off points for BMI, see table 4 in Cole et al, 200053) on the pharmacokinetics of carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, doxorubicin, etoposide, methotrexate and vincristine and their known metabolites (if applicable) in pediatric patients (0-17 years).<br>-To correlate pharmacokinetics of pediatric patients with clinical and laboratory toxicity.