Vincristine Pharmacokinetics in Infants (NCT05359237)
A Pharmacokinetic Study of VinCRIStine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama โ Birmingham, Alabama
Age range: Not specified to 12 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- Children's Hospital of Alabama โ Birmingham, Alabama
- Children's Hospital Los Angeles โ Los Angeles, California
- Children's Hospital of Orange County โ Orange, California
- UCSF Medical Center-Mission Bay โ San Francisco, California
- Children's Hospital Colorado โ Aurora, Colorado
- Children's National Medical Center โ Washington D.C., District of Columbia
- Lurie Children's Hospital-Chicago โ Chicago, Illinois
- University of Chicago Comprehensive Cancer Center โ Chicago, Illinois
- Riley Hospital for Children โ Indianapolis, Indiana
- Johns Hopkins University/Sidney Kimmel Cancer Center โ Baltimore, Maryland
- Dana-Farber Cancer Institute โ Boston, Massachusetts
- C S Mott Children's Hospital โ Ann Arbor, Michigan
- University of Minnesota/Masonic Cancer Center โ Minneapolis, Minnesota
- Washington University School of Medicine โ St Louis, Missouri
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center โ New York, New York
- New York Medical College โ Valhalla, New York
- Duke University Medical Center โ Durham, North Carolina
- Cincinnati Children's Hospital Medical Center โ Cincinnati, Ohio
- Nationwide Children's Hospital โ Columbus, Ohio
- Children's Hospital of Philadelphia โ Philadelphia, Pennsylvania
- Children's Hospital of Pittsburgh of UPMC โ Pittsburgh, Pennsylvania
- Saint Jude Children's Research Hospital โ Memphis, Tennessee
- Vanderbilt University/Ingram Cancer Center โ Nashville, Tennessee
- UT Southwestern/Simmons Cancer Center-Dallas โ Dallas, Texas
- Cook Children's Medical Center โ Fort Worth, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.