Vincristine Pharmacokinetics in Infants
Condition(s) studied
Investigational drug(s) / intervention(s)
Biospecimen Collection: Undergo collection of blood samples
Vincristine: Given IV per standard of care
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.
Eligibility
Primary outcome measure(s)
- Area under the concentration time curve for the elimination phase (AUCelim) by age group — Up to 24 hours post vincristine dose
Estimate (95% CI) of the mean area under the concentration time curve for the elimination phase assessed at 0, 2, 6-8, and 18-24 hours after vinCRISTine dose by age group.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | |
| Children's Hospital Los Angeles | Los Angeles | California | |
| Children's Hospital of Orange County | Orange | California | |
| UCSF Medical Center-Mission Bay | San Francisco | California | |
| Children's Hospital Colorado | Aurora | Colorado | |
| Children's National Medical Center | Washington D.C. | District of Columbia | |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | |
| Riley Hospital for Children | Indianapolis | Indiana | |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | |
| Dana-Farber Cancer Institute | Boston | Massachusetts | |
| C S Mott Children's Hospital | Ann Arbor | Michigan | |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | |
| New York Medical College | Valhalla | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| Nationwide Children's Hospital | Columbus | Ohio | |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | |
| Cook Children's Medical Center | Fort Worth | Texas | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | |
| Seattle Children's Hospital | Seattle | Washington | |
| Queensland Children's Hospital | South Brisbane | Queensland | |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
More Children's Oncology Group trials in Australia
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05359237 on ClinicalTrials.gov ↗ ← All trials in Australia