Dinutuximab and Intensive Therapy for High-Risk Neuroblastoma in Children
This study aims to evaluate whether dinutuximab and intensive therapy improve survival outcomes in children with high-risk neuroblastoma.
Biospecimen Collection
+ Bone Marrow Aspiration
+ Bone Marrow Biopsy
Neoplasms+8
+ Neoplasms by Histologic Type
+ Neoplasms, Germ Cell and Embryonal
Treatment Study
Summary
Study start date: April 19, 2024
Actual date on which the first participant was enrolled.This study focuses on children who have been newly diagnosed with high-risk neuroblastoma, a type of cancer that develops from immature nerve cells. The goal is to find out if adding a drug called dinutuximab to the usual intense cancer treatments can help these children survive longer without their cancer coming back. Researchers want to see if this combination can also improve overall survival rates and how well the cancer responds to treatment at the end of the initial treatment phase. Additionally, they are examining whether this new approach causes different side effects compared to standard treatments and how factors like tumor characteristics and patient conditions affect outcomes. Participants in the study will undergo a series of treatments that include several cycles of chemotherapy drugs administered through an IV, and in some cases, orally. The study involves cycles of treatment, and based on how the tumor responds, patients may proceed to additional cycles or move on to a phase called Consolidation, which includes stem cell transplants. Throughout the study, tests such as scans and biopsies are conducted to evaluate the tumor's response to treatment. The study aims to measure results like event-free survival (how long patients live without the cancer coming back) and overall survival. Potential risks include common side effects of chemotherapy and immunotherapy, but the study also explores possible improvements in survival and quality of life for patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.478 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 30 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 175 locations
Children's Hospital of Alabama
Birmingham, United StatesOpen Children's Hospital of Alabama in Google MapsUSA Health Strada Patient Care Center
Mobile, United StatesBanner Children's at Desert
Mesa, United StatesPhoenix Childrens Hospital
Phoenix, United States