PEPN22P1, A Pharmacokinetic Study of VinCRIStine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods
PEPN22P1
What is the goal of the study?
This pilot study will test the hypothesis that infant-specific, BSA-banded dosing tables will result in uniform drug exposure in infants and older children, with tolerable toxicity and without compromising the therapeutic effectiveness. The uniformity of vinCRIStine exposure (as measured by area under the curve, or AUC) using the new infant dosing method will be assessed by studying its pharmacokinetics in four age groups: ≤6 months (n=20), >6 months to ≤12 months (n=10), >12 months to ≤36 months (n=10), and >36 months to ≤12 years (n=10). Post-infusion levels will be drawn at 2 (±15 minutes), 6 to 8, and 18 to 24 hours after a dose. VinCRIStine levels will be measured by High Performance Liquid Chromatography with tandem mass spectrometry (HPLC/MS/MS). The elimination portion of the plasma-concentration time curve (which accounts for >80% of the total AUC), will be estimated using Phoenix software. Variability (as measured by coefficient of variation, or CV) will be assessed within and across age groups. Information on dose delays, reductions or omissions related to toxicity will be collected. Each subject will be screened for CYP3A4/5 polymorphisms, which can contribute to variability in AUC.
Who can participate in the study?
Please contact the study team listed below to learn more.