CHildren Treated With Vincristine: A Trial Regarding Pharmacokinetics, DNA And Toxicity of Targeted Therapy In Pediatric Oncology Patients.

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moi University
• Collaborators: Amsterdam UMC, location VUmc; Princess Maxima Center for Pediatric Oncology
• Treatments: Vincristine

Criteria

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)