Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05359237 · ClinicalTrials.gov registry record
Vincristine Pharmacokinetics in Infants
A clinical trial of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Children's Oncology Group.
- Active
- Registry status
- 83
- Enrollment target
- 20
- Study locations
NCT05359237: Active study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Children's Oncology Group.
NCT05359237 is a study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 83 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05359237, a study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- 83 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Vincristine
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- UCSF Medical Center-Mission Bay - San Francisco
Illinois
- Lurie Children's Hospital-Chicago - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
- New York Medical College - Valhalla
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2022-11-16 |
| Est. Completion | 2026-09-30 |
What the registry record for NCT05359237 still lists
NCT05359237 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT05359237 names 20 study sites across 15 states, led by California, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT05359237 about?
NCT05359237 is a clinical study titled "Vincristine Pharmacokinetics in Infants". 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 antica...
What is the current status of trial NCT05359237?
This trial is currently active not recruiting. The enrollment target is 83 participants. The study started on 2022-11-16. Estimated completion is 2026-09-30.
What conditions does trial NCT05359237 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm.
What interventions are being tested in trial NCT05359237?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Vincristine (DRUG).
Who is sponsoring clinical trial NCT05359237?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05359237 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05359237's enrollment target sits among peer trials
83 99th of 176 higher than 78 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy
RECRUITING
-
Investigating Memory and Physical Activity After Cancer Treatment in Survivors of Adolescent and Young Adult Cancers
RECRUITING
-
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
RECRUITING · Phase 1
-
Exercise Program (TEAM Me) for the Improvement of Movement and Mobility in Pediatric and Adolescent and Young Adult Patients With Cancer Undergoing a Blood Stem Cell Transplant
RECRUITING · NA
-
Voices: Messages of Wisdom and Hope in the Face of Illness
RECRUITING
-
Collection and Storage of Tissue and Blood Samples From Patients With Cancer
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02974647 · 83 participants · Phase 2
Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
- NCT03919292 · 83 participants · Phase 1
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
- NCT04626674 · 83 participants · Phase 1
A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
- NCT05277168 · 83 participants · Phase 1
A Trial TO Evaluate THE Safety, Tolerability, Pharmacokinetics, AND Efficacy OF Shr-a1904 IN Subjects With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI