To hear about similar clinical trials, please enter your email below
Trial Title:
CHildren Treated With Vincristine: A Trial Regarding Pharmacokinetics, DNA And Toxicity of Targeted Therapy In Pediatric Oncology Patients.
NCT ID:
NCT05844670
Condition:
Pediatric Cancer
Conditions: Official terms:
Neoplasms
Vincristine
Conditions: Keywords:
Pharmacokinetics
Vincristine-induced peripheral neuropathy
Pediatric oncology
Vincristine
Individualized dosing
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This will be a prospective cohort study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Vincristine
Description:
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.
Arm group label:
Vincristine
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.
Detailed description:
Vincristine is among the most widely used and potentially effective chemotherapeutic
agents in pediatric oncology patients. However, in black African children it may be sub
optimally dosed due to genetic differences in the metabolism of vincristine. This study
aims to optimize the dosing regimen of vincristine while carefully monitoring toxicity.
This will be a prospective cohort study consisting of two parts: a feasibility study and
the rest of the study. In the feasibility study, 15 children aged 5-14 years who are
scheduled to receive at least 2 vincristine administrations can be included. After the
administration of vincristine, venous blood samples and finger prick blood samples will
be taken to determine the vincristine concentrations. The samples will be shipped to and
analyzed in the Netherlands to determine the vincristine concentration in each sample.
Based on this, a dose advise will be given for subsequent vincristine administrations.
This cycle will be repeated maximum 2 times but maximum 1 dose advice is given. Toxicity
will be monitored by determination of the bilirubin, by questionnaires and by physical
examination to check for signs of peripheral neuropathy. In the rest of the study, in
which 85 children will be included, only finger prick samples will be taken.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
2 Years
Maximum age:
14 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Moi Teaching and Referral Hospital
Address:
City:
Eldoret
Zip:
P.o. Box 3-30100
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
Aniek Uittenboogaard, MD
Phone:
+31631293157
Email:
a.uittenboogaard@amsterdamumc.nl
Contact backup:
Last name:
Festus M Njuguna, MD, PhD
Phone:
+254532032393
Email:
muigaifes2000@yahoo.com
Start date:
April 20, 2023
Completion date:
November 1, 2024
Lead sponsor:
Agency:
Moi University
Agency class:
Other
Collaborator:
Agency:
Princess Maxima Center for Pediatric Oncology
Agency class:
Other
Collaborator:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Source:
Moi University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844670
