PINOCCHIO (multiple types of cancer)
Recruiting
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
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
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.
In order to participate in a study please refer to your/your child’s doctor.
Last reviewed
Last reviewed
March 23, 2026
Study details
- Study details
Official title
PINOCCHIO-study: Pharmacokinetics of chemotherapeutic agents and tyrosine kinase inhibitors in pediatric oncologyCancer type
All types of cancer that require standard of care with chemotherapy (carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, doxorubicin, etoposide, methotrexate, and/or vincristine) or TKIs (ALK, BCR-ABL, MEK, VEGFR, EGFR, FLT3, and NTRK inhibitors)
Type of study
Prospective observational studyMaximum number of patients
For stratum I, we aim to collect data from approximately 10 infants (0-12 months), 10 children (1-11 years) and 10 adolescents (12-17 years) for each chemotherapeutic agent. For stratum II we expect approximately 10 patients per agent.Start date
Stratum I opened on 27-02-2019. Stratum II is not open yet (expected in the first quarter of 2022)Status
Stratum I is open. Stratum II is awaiting the response of the medical ethics review committee.Local Principal Investigator
Prof. dr. C.M. ZwaanSponsor
Princess Máxima Center for pediatric oncologyApproval
This study has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
NL63037.078.18, NTR NL7527
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.