Home › Trials › NCT05359237

Comparing vincristine dosing methods in infants and young children

A Pharmacokinetic Study of VinCRIStine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods

Observational Children's Oncology Group · NCT05359237

This study is testing a new way to dose the cancer drug vincristine in infants and young children to see if it works better than the standard method used for older kids.

Quick facts

Study typeObservational
Enrollment83 (estimated)
AgesN/A to 12 Years
SexAll
SponsorChildren's Oncology Group Research network
Locations29 sites (Birmingham, Alabama and 28 other locations)
Trial IDNCT05359237 on ClinicalTrials.gov

What this trial studies

This observational pilot trial aims to compare drug exposure levels of vincristine, an anticancer drug, in infants and young children using a new dosing method against the standard body surface area (BSA) dosing used for older children. The study will validate BSA-banded infant dosing tables by measuring the area under the concentration-time curve for the elimination phase (AUCelim) of vincristine. Blood samples will be collected at various time points to assess drug exposure and variability in drug metabolism among different age groups. The trial also explores the correlation between drug exposure and genetic factors affecting drug metabolism.

Who should consider this trial

Good fit: Ideal candidates for this study are infants and young children up to 12 years old who are newly diagnosed or relapsed cancer patients receiving vincristine treatment.

Not a fit: Patients who are older than 12 years or those not receiving vincristine as part of their treatment regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective dosing of vincristine for infants and young children with cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown the importance of tailored dosing in pediatric oncology, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients must be =\< 12 years of age at the time of study enrollment. Patients will be stratified into 4 age groups:

  * 0 to 6 months
  * 6 months and 1 day to 12 months
  * 12 months and 1 day to 36 months
  * 36 months and 1 day to 12 years with a BSA ≥ 0.6 m\^2
* Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m\^2 dose level
* Any disease status
* Patients must have a Lansky performance status of 50 or higher
* Patients must be receiving a treatment regimen that includes 1.5 mg/m\^2 vinCRIStine (maximum dose 2 mg)
* Patients with a BSA \< 0.6 m\^2 must be dosed according to the Children's Oncology Group (COG) BSA-banded infant dosing table for the 1.5mg/m2 dose level for vinCRIStine

  * Note: Patients can be studied after any dose of vinCRIStine
* Patients who are NOT enrolled on a COG clinical trial and who have a BSA \< 0.6 m\^2 and who are being dosed according to another infant dosing method (e.g., the 30-Rule) can receive a dose of vinCRIStine from the infant dosing table for the pharmacokinetic study. These patients will NOT be part of the Dose Modification Assessment
* Patients with a seizure disorder may be enrolled if on allowable anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days
* Nervous system toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\]) version (v)5 resulting from prior therapy must be grade =\< 2
* Central venous access device in place (e.g., percutaneous indwelling central catheter \[PICC\], port, Broviac) or scheduled to be placed prior to the dose of vinCRIStine and that can be used for pharmacokinetic (PK) sampling
* VinCRIStine may be given as an outpatient, as long as all sample time points can be collected, which will require return for hour 24 sampling

Exclusion Criteria:

* Azoles antifungals and macrolide antibiotics: Patients who are currently receiving an azole or macrolide (e.g., fluconazole, isavuconazole, itraconazole, posaconazole, voriconazole, ketoconazole, eryromycin, clarithromycin, azithromycin, roxithromycin, or telithromycin) are not eligible
* CYP3A4/5 inducers/inhibitors: Patients receiving any medications or substances that are considered moderate or strong inhibitors or inducers of CYP3A4/5 are not eligible. Moderate or strong inducers or inhibitors of CYP3A4/5 should be avoided from 14 days prior to enrollment to the end of the study.

  * Note the following are allowed:

    * Dexamethasone for CNS tumors or metastases, on a stable dose
    * Aprepitant for management of nausea and vomiting
* Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible.
* Patients with Charcot-Marie-Tooth disease
* A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities
* Patients being treated on a Children Oncology Group (COG) clinical trial, that does not use the infant dosing tables for vinCRIStine are not eligible for this study.
* Patients receiving a modified dose (\< 1.5 mg/m\^2) of vinCRIStine due to prior toxicity
* Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study

Where this trial is running

Birmingham, Alabama and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.