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Vinca alkaloids

Vincristine Pharmacokinetics in Infants

N/A
Recruiting
Led By Emily Blauel
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 days
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Blood Cancers
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the concentration time curve for the elimination phase (AUCelim) by age group
Secondary study objectives
Intra- and inter-age coefficient of variation (CV)
Other study objectives
Correlation of AUC for the elimination phase with CYP3A4 and CYP3A5 single nucleotide polymorphisms (SNPs)
Number of patients requiring vincristine dose modifications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Vincristine
2003
Completed Phase 4
~2970

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,915 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,497 Total Patients Enrolled
2 Trials studying Blood Cancers
112 Patients Enrolled for Blood Cancers
Emily BlauelPrincipal InvestigatorPediatric Early Phase Clinical Trial Network
~25 spots leftby Dec 2025