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Clinical Trials in Canada / NCT05359237
Active, not recruiting Observational

Vincristine Pharmacokinetics in Infants

NCT05359237 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2022-11-16
Last updated
2026-02-06

Condition(s) studied

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Investigational drug(s) / intervention(s)

Biospecimen CollectionVincristine →

Biospecimen Collection: Undergo collection of blood samples

Vincristine: Given IV per standard of care

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.

Eligibility

Sex
ALL
Min age
—
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (29)

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

More Children's Oncology Group trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05359237 on ClinicalTrials.gov ↗ ← All trials in Canada