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Vincristine Pharmacokinetics in Infants
NCT05359237 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Vincristine
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- Children's Hospital of Orange County — Orange
- UCSF Medical Center-Mission Bay — San Francisco
Illinois
- Lurie Children's Hospital-Chicago — Chicago
- University of Chicago Comprehensive Cancer Center — Chicago
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York
- New York Medical College — Valhalla
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Nationwide Children's Hospital — Columbus
Alabama
- Children's Hospital of Alabama — Birmingham
Colorado
- Children's Hospital Colorado — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Indiana
- Riley Hospital for Children — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2022-11-16 |
| Est. Completion | 2026-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05359237
The ClinicalTrials.gov registry entry for NCT05359237 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05359237 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05359237 about?
NCT05359237 is a clinical study titled "Vincristine Pharmacokinetics in Infants". 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 antica...
What is the current status of trial NCT05359237?
This trial is currently active not recruiting. The enrollment target is 83 participants. The study started on 2022-11-16. Estimated completion is 2026-09-30.
What conditions does trial NCT05359237 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05359237?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Vincristine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05359237?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05359237 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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