Fact CheckerSign in

NCT05359237Active, not recruiting

Vincristine Pharmacokinetics in Infants

A Pharmacokinetic Study of VinCRIStine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
83 (estimated)
First submitted
28 Apr 2022
Start date
16 Nov 2022
Primary completion date
30 Sept 2026
Lead sponsor
Children's Oncology Group
NCT number
NCT05359237

What you commit to

  • Study type: Observational
  • Planned participants: 83
  • From 16 Nov 2022 to the primary completion date, 30 Sept 2026
  • 29 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 receiving a modified dose (\< 1.5 mg/m\^2) of vinCRIStine due to prior toxicity

Other illness

  • Patients with Charcot-Marie-Tooth disease
  • A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities

Other

  • 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 who in the opinion of the investigator may not be able to comply with the sampling requirements of the study

Who the study is looking for

  • 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

Age in the registry: - to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queensland Children's Hospital
Coordinator of this site? Confirm its status
South BrisbaneAustraliaUnknown status
Centre Hospitalier Universitaire Sainte-Justine
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
C S Mott Children's Hospital
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Children's Hospital of Alabama
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Lurie Children's Hospital-Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Nationwide Children's Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Cook Children's Medical Center
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Riley Hospital for Children
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Children's Hospital Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Saint Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Children's Hospital of Orange County
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
Children's Hospital of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
UCSF Medical Center-Mission Bay
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
New York Medical College
Coordinator of this site? Confirm its status
ValhallaUnited StatesUnknown status
Children's National Medical Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.