← Back to Search

Vinca alkaloids

Observational (SOC vincristine, biospecimen collection) for Blood Cancers

Phase < 1
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

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.

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

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

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 2
~1720
Vincristine
2003
Completed Phase 4
~2910

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,712 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,704 Previous Clinical Trials
40,931,368 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Emily BlauelPrincipal InvestigatorPediatric Early Phase Clinical Trial Network

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for individuals interested in participating in this research project?

"Affirmative. Details displayed on clinicaltrials.gov show that this research, which was made public on November 14th 2022, is still in search of participants. 59 patients are required from 6 different medical facilities."

Answered by AI

How many people have registered for this medical experiment?

"Yes, according to clinicaltrials.gov, this experiment is still actively seeking participants since its original posting on November 14th 2022 and latest update occurring four days later on the 18th of that same month. 59 volunteers are needed at six different locations for the trial."

Answered by AI

How many physical sites can participants access this trial at?

"Patients may be accepted at Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center in Houston, Texas, Children's Hospital of Pittsburgh of UPMC in Pittsburgh, Pennsylvania and C S Mott Children's Hospital in Ann Arbor, Michigan as well as 6 other sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vincristine Pharmacokinetics in Infants
2022. "Vincristine Pharmacokinetics in Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359237.
~7 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top