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NCT05359237 · ClinicalTrials.gov registry record
Vincristine Pharmacokinetics in Infants
A clinical trial of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Children's Oncology Group.
- Active
- Registry status
- 83
- Enrollment target
- 20
- Study locations
NCT05359237 is a study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 83 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT05359237, a study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- 83 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
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.
NCT05359237 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Illinois, New York.
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.
What interventions are being tested in trial NCT05359237?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Vincristine (DRUG).
Who is sponsoring clinical trial NCT05359237?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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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