Vincristine Pharmacokinetics in Infants

Recruiting in Palo Alto (17 mi)

+28 other locations

Overseen ByEmily Blauel

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Oncology Group

No Placebo Group

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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 Criteria

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Observational (SOC vincristine, biospecimen collection)Experimental Treatment2 Interventions

Patients receive vincristine IV per SOC. Patients undergo collection of blood samples at baseline (before first vincristine dose), and 2, 6-8, and 18-24 hours after a dose of vincristine. Patients may also undergo collection of blood samples with a second SOC vincristine dose at the same time points.

Vincristine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vincristine for: