An observational study in Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, sponsored by Children's Oncology Group. Active, not recruiting at 29 sites in 3 countries. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Children's Oncology Group · Observational
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.
PRIMARY OBJECTIVE:
I. To validate body surface area (BSA)-banded infant dosing tables by comparing vinCRIStine drug exposure, defined as the area under the concentration-time curve for the elimination phase (AUCelim), in infants and young children dosed according to the table to older children dosed according to BSA.
SECONDARY OBJECTIVE:
I. To estimate intra- and inter-age group variability (CV) using non-compartmental analysis (NCA) and population pharmacokinetic (PK) methods.
EXPLORATORY OBJECTIVES:
I. To correlate higher AUCelim with the presence of functionally impaired single nucleotide polymorphisms (SNP) of CYP3A4 and CYP3A5.
II. To assess vinCRIStine dose modifications in infants receiving weekly vinCRIStine dosed according to the BSA-banded infant dosing tables.
OUTLINE:
Patients receive vincristine intravenously (IV) per standard of care (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.
Patients are followed for dose modifications for a period of 42 days (when receiving weekly dosing of vincristine).
1,464 studies on the registry are indexed under Hematologic Neoplasms; 432 are open to participants now.
This study's planned enrollment of 83 is below the median of 182 across 325 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
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Infants and young children receiving treatment regimen that includes vinCRIStine
Patients must be =\< 12 years of age at the time of study enrollment. Patients will be stratified into 4 age groups:
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
Exclusion Criteria:
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:
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.
Procedure: Biospecimen Collection · Drug: Vincristine
Undergo collection of blood samples
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given IV per standard of care
Also known as: LCR, Leurocristine, VCR, Vincrystine
Area under the concentration time curve for the elimination phase (AUCelim) by age group
Estimate (95% CI) of the mean area under the concentration time curve for the elimination phase assessed at 0, 2, 6-8, and 18-24 hours after vinCRISTine dose by age group.
Time frame: Up to 24 hours post vincristine dose
Intra- and inter-age coefficient of variation (CV)
Estimate of the intra- and inter-age coefficient of variation using non-compartmental analysis (NCA) and population pharmacokinetic (PK) methods.
Time frame: Up to 42 days
Correlation of AUC for the elimination phase with CYP3A4 and CYP3A5 single nucleotide polymorphisms (SNPs)
Correlate AUCelim with the presence of functionally impaired single nucleotide polymorphisms (SNP) of CYP3A4 and CYP3A5.
Time frame: Up to 24 hours
Number of patients requiring vincristine dose modifications
Number of patients requiring vincristine dose modifications stratified by age group.
Time frame: Up to 42 days
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group