Vincristine Pharmacokinetics in Infants

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Neoplasms

Clinical Trial Details

NCT number	NCT05359237
Study type	Observational
Source	Children's Oncology Group
Contact
Status	Recruiting
Phase
Start date	November 16, 2022
Completion date	July 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06030427` - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT05660421` - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors	Phase 2
Suspended	`NCT04060849` - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY	Phase 1
Recruiting	`NCT06192875` - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed	`NCT04122118` - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor	N/A
Active, not recruiting	`NCT04940299` - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma	Phase 2
Active, not recruiting	`NCT03168737` - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients	Phase 1
Active, not recruiting	`NCT06062901` - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors	N/A
Active, not recruiting	`NCT02444741` - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer	Phase 1/Phase 2
Terminated	`NCT04081298` - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors	N/A
Active, not recruiting	`NCT04555837` - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer	Phase 1/Phase 2
Completed	`NCT04983901` - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN	Phase 2
Active, not recruiting	`NCT04602026` - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer	N/A
Recruiting	`NCT04871542` - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting	`NCT04592250` - Financial Toxicity in Cancer Patients
Recruiting	`NCT05112614` - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting	`NCT04296305` - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain	Phase 4
Recruiting	`NCT05873608` - Communication Issues in Patient and Provider Discussions of Immunotherapy	N/A
Recruiting	`NCT02464696` - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure	N/A