Clinical trial · Interventional
CHildren Treated With Vincristine: A Trial Regarding Pharmacokinetics, DNA And Toxicity of Targeted Therapy In Pediatric Oncology Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to individualize the dosage of vincristine, a chemotherapy drug, in children with cancer. The main question it aims to answer is: can vincristine dosage be optimized while carefully monitoring toxicity. The following will happen: * Participants will receive vincristine according to the institutional treatment protocol. * After receiving vincristine, blood samples will be taken at three time points. * The amount of vincristine in the blood samples will be determined. * If the amount of vincristine in the blood samples is lower than the reference and the participants do not experience toxicity due to vincristine, the dose of vincristine may be increased. * Toxicity will be carefully monitored.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vincristine
- description
- A dose advice for vincristine will be given based on vincristine concentrations in blood samples and toxicity monitoring.
- interventionNames
- Drug: Vincristine
Primary outcomes (1)
- measure
- Adapting vincristine dosage
- timeFrame
- Through study completion, an average of four months per patient (depending on treatment protocol).
- description
- The number of patients in whom it is possible to adapt vincristine dosage based on vincristine concentrations in the blood at three time points and the presence of side-effects.
Secondary outcomes (3)
- measure
- Vincristine-induced peripheral neuropathy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 14 Years
Show eligibility criteria text
Feasibility study: Inclusion Criteria: * Black patients aged 5-14 years with a malignancy for which they are scheduled to receive a minimum of two VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma. * Written informed consent Exclusion Criteria: * Severe malnutrition * Total bilirubin \>3 times upper limit of normal * Pre-existent severe mental retardation e.g. Down syndrome * Pre-existent peripheral neuropathy (CTCAE constipation, peripheral sensory neuropathy, peripheral motor neuropathy, or neuralgia ≥ 2 or ped-mTNS ≥ 5) Rest of the study: Inclusion Criteria: * Black patients aged 2-14 years with a malignancy for which they are scheduled to receive a minimum of four VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma. * Written informed consent Exclusion Criteria: * Severe malnutrition * Total bilirubin \>3 times upper limit of normal * Pre-existent severe mental retardation e.g. Down syndrome * Pre-existent peripheral neuropathy (CTCAE constipation, peripheral sensory neuropathy, peripheral motor neuropathy, or neuralgia ≥ 2 or ped-mTNS ≥ 5)
References
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