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

NCT05844670 | Unknown Phase 4 DMC

• 1 other identifier: V314092022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacokinetics; Vincristine-induced peripheral neuropathy; Pediatric oncology; Vincristine; Individualized dosing

Outcome Measures

Primary Outcomes (1)

• Adapting vincristine dosage

  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.

  Through study completion, an average of four months per patient (depending on treatment protocol).

Secondary Outcomes (3)

• Vincristine-induced peripheral neuropathy

  Through study completion, an average of four months per patient (depending on treatment protocol).

• Genetics

  Through study completion, an average of four months per patient (depending on treatment protocol).

• Vincristine pharmacokinetics

  Through study completion, an average of four months per patient (depending on treatment protocol).

Study Arms (1)

Vincristine

EXPERIMENTAL

A dose advice for vincristine will be given based on vincristine concentrations in blood samples and toxicity monitoring.

Drug: Vincristine

Interventions

Vincristine DRUG

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.

Vincristine

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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)

Sponsors & Collaborators

• Moi University: lead
• Princess Maxima Center for Pediatric Oncology: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Rift Valley, P.o. Box 3-30100, Kenya

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Vincristine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Festus M Njuguna, MD, PhD

  Moi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aniek Uittenboogaard, MD

CONTACT

+31631293157; a.uittenboogaard@amsterdamumc.nl

Festus M Njuguna, MD, PhD

CONTACT

+254532032393; muigaifes2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective cohort study.

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: April 20, 2023
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The study protocol and ICF is already available upon request. Upon completion of the study, the SAP, CSR and analytic code will be accessible for unlimited amount of time.
• Access Criteria: The data are available upon reasonable request.

Locations

KE (1)