Vincristine Pharmacokinetics in Infants

Running, not enrolling

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID: NCT05359237
Run by: Children's Oncology Group
People needed: 83
Starts: 2022-11-16
Expected to finish: 2026-09-30
Last updated by the study team: 2026-02-06

Who can join

Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must be =< 12 years of age at the time of study enrollment. Patients will be stratified into 4 age groups:
0 to 6 months
6 months and 1 day to 12 months
12 months and 1 day to 36 months
36 months and 1 day to 12 years with a BSA ≥ 0.6 m\^2
Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m\^2 dose level
Any disease status
Patients must have a Lansky performance status of 50 or higher
Patients must be receiving a treatment regimen that includes 1.5 mg/m\^2 vinCRIStine (maximum dose 2 mg)
Patients with a BSA < 0.6 m\^2 must be dosed according to the Children's Oncology Group (COG) BSA-banded infant dosing table for the 1.5mg/m2 dose level for vinCRIStine
Note: Patients can be studied after any dose of vinCRIStine
Patients who are NOT enrolled on a COG clinical trial and who have a BSA < 0.6 m\^2 and who are being dosed according to another infant dosing method (e.g., the 30-Rule) can receive a dose of vinCRIStine from the infant dosing table for the pharmacokinetic study. These patients will NOT be part of the Dose Modification Assessment
Patients with a seizure disorder may be enrolled if on allowable anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days
Nervous system toxicities (Common Terminology Criteria for Adverse Events [CTCAE]) version (v)5 resulting from prior therapy must be grade =< 2
Central venous access device in place (e.g., percutaneous indwelling central catheter [PICC], port, Broviac) or scheduled to be placed prior to the dose of vinCRIStine and that can be used for pharmacokinetic (PK) sampling
VinCRIStine may be given as an outpatient, as long as all sample time points can be collected, which will require return for hour 24 sampling

You may not qualify if…

Azoles antifungals and macrolide antibiotics: Patients who are currently receiving an azole or macrolide (e.g., fluconazole, isavuconazole, itraconazole, posaconazole, voriconazole, ketoconazole, eryromycin, clarithromycin, azithromycin, roxithromycin, or telithromycin) are not eligible
CYP3A4/5 inducers/inhibitors: Patients receiving any medications or substances that are considered moderate or strong inhibitors or inducers of CYP3A4/5 are not eligible. Moderate or strong inducers or inhibitors of CYP3A4/5 should be avoided from 14 days prior to enrollment to the end of the study.
Note the following are allowed:
Dexamethasone for CNS tumors or metastases, on a stable dose
Aprepitant for management of nausea and vomiting
Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible.
Patients with Charcot-Marie-Tooth disease
A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities
Patients being treated on a Children Oncology Group (COG) clinical trial, that does not use the infant dosing tables for vinCRIStine are not eligible for this study.
Patients receiving a modified dose (< 1.5 mg/m\^2) of vinCRIStine due to prior toxicity
Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study

Where it is running

Children's Hospital of Alabama — Birmingham, Alabama, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
Children's Hospital of Orange County — Orange, California, United States
UCSF Medical Center-Mission Bay — San Francisco, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Riley Hospital for Children — Indianapolis, Indiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
C S Mott Children's Hospital — Ann Arbor, Michigan, United States
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
New York Medical College — Valhalla, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Saint Jude Children's Research Hospital — Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
Cook Children's Medical Center — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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