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Active, not recruiting No phase listed Observational

Vincristine Pharmacokinetics in Infants

ClinicalTrials.gov ID: NCT05359237

Public ClinicalTrials.gov record NCT05359237. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 9:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.

Study identification

NCT ID
NCT05359237
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Children's Oncology Group
Network
Enrollment
83 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 12 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 16, 2022 (Actual)
Primary completion
Sep 30, 2026 (Estimated)
Completion
Sep 30, 2026 (Estimated)
Last update posted
Feb 6, 2026

2022 – 2026

United States locations

U.S. sites
27
U.S. states
18
U.S. cities
26
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Children's Hospital of Orange County Orange California 92868 —
UCSF Medical Center-Mission Bay San Francisco California 94158 —
Children's Hospital Colorado Aurora Colorado 80045 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Lurie Children's Hospital-Chicago Chicago Illinois 60611 —
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
C S Mott Children's Hospital Ann Arbor Michigan 48109 —
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455 —
Washington University School of Medicine St Louis Missouri 63110 —
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 —
New York Medical College Valhalla New York 10595 —
Duke University Medical Center Durham North Carolina 27710 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 —
Saint Jude Children's Research Hospital Memphis Tennessee 38105 —
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232 —
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 —
Cook Children's Medical Center Fort Worth Texas 76104 —
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030 —
Seattle Children's Hospital Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05359237, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 6, 2026 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05359237 live on ClinicalTrials.gov.

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