Who can enter
- Children receiving chemotherapy or Tyrosine Kinase Inhibitors (TKIs) as standard of care
- Age ≤18 years for stratum I and ≤21 years for stratum II
Goal
In the PINOCCHIO study we investigate to what extent a young child's body handles chemotherapy and TKIs differently than an adult or older child's body. We do so by measuring the concentration of the drug in the blood. This allows us to find out if the dose needs to be adjusted for children.
In Stratum I, we do this for nine commonly used chemotherapy agents: carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, doxorubicin, etoposide, methotrexate, and vincristine.
In stratum II we do this for different TKIs (ALK, BCR-ABL, MEK, VEGFR, EGFR, FLT3 and NTRK inhibitors).
Background
Most of the information on the use of chemotherapeutic agents and TKIs is based on research in adults. However, this information is also used for children, without knowing whether this is correct for this patient group.
A child's body is in full development during the first years of life. As a result, the metabolism, distribution, and excretion of the chemotherapeutic agent or TKI in the body (also known as pharmacokinetics) may be different. The lack of information about how a child’s body processes these drugs may lead to overdosing or underdosing. And as a result: a higher risk or less effectiveness of the treatment.
With this study we want to look at the differences in pharmacokinetics between adults and children of different ages, in order to find out whether the treatment should be adapted for children.
Children participating in this study will have extra blood samples taken at several times after the administration of chemotherapy or TKI. No changes will be made to the chemotherapy or TKI treatment when a child participates in this study.