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

NCT05844670 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Pediatric Cancer

Interventions

DRUG

Vincristine

The initial vincristine dosage will be according to institutional treatment protocol. After vincristine administration, three blood samples will be taken at T=1, T=1.5 and T=4 hours. The concentration of vincristine will be analyzed in the samples. If the concentration of 2 or more samples is lower than the reference concentration and there is no toxicity, an advice will be given to increase dosage by 20%. Whether or not a dosage is given, vincristine concentrations will be measured again for the next dose administration. For the feasibility study, both venous blood samples and finger prick blood samples using Mitra tips will be taken. The cycle can be repeated maximum 2 times. For the rest of the study, finger prick blood samples using Mitra tips will be taken. The cycle can be repeated maximum 3 times. Toxicity will be monitored through physical exam and questionnaire, bilirubin levels and clinical status of the patient.

Sponsors & Collaborators

  • Princess Maxima Center for Pediatric Oncology

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Moi University

    lead OTHER

Principal Investigators

  • Festus M Njuguna, MD, PhD · Moi University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2024-08-01
Completion
2024-11-01

Countries

  • Kenya

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844670 on ClinicalTrials.gov