RecruitingPhase 1NCT06485947

Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma

Phase Ib Study Combining Dinutuximab Beta With Induction Chemotherapy Regimens in Patients With Newly Diagnosed High-risk Neuroblastoma


Sponsor

Princess Maxima Center for Pediatric Oncology

Enrollment

38 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is: • to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens Participants will receive: * GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals. * Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.


Eligibility

Min Age: 18 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called dinutuximab beta — an antibody that targets neuroblastoma cancer cells — combined with two different chemotherapy regimens, in children and young people with high-risk stage M neuroblastoma (a childhood cancer that starts in nerve cells) who have not yet received any treatment. **You may be eligible if...** - Your child has been diagnosed with high-risk Stage M neuroblastoma - Your child is between 18 months and 18 years old - Your child weighs more than 12 kg - Your child's liver, kidneys, and heart are functioning adequately - Your child has not yet received any cancer treatment - Parents or legal guardians have provided written informed consent **You may NOT be eligible if...** - Your child has already received cancer treatment for neuroblastoma - Your child requires certain medications prohibited by the study (e.g., corticosteroids) - Your child has significant organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDinutuximab beta

Combination of immunotherapy with standard chemotherapy

DRUGchemotherapy treatment called GPOH

chemotherapy treatment called GPOH

DRUGchemotherapy treatment called rapid COJEC

chemotherapy treatment called rapid COJEC


Locations(1)

Princess Maxima center for pediatric oncology

Utrecht, Utrecht, Netherlands

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NCT06485947


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