Actively Recruiting
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-07-08
38
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
Sponsors
P
Princess Maxima Center for Pediatric Oncology
Lead Sponsor
E
EUSA Pharma, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of neuroblastoma Stage M according to SIOPEN modified INRG and INSS criteria
- Age 18 months to less than 18 years
- Body weight greater than 12 kg
- Alanine transaminase and aspartate aminotransferase less than 10 times upper limit of normal (ULN), total bilirubin less than 1.5 times ULN based on age-specific reference ranges
- Calculated glomerular filtration rate greater than 60 mL/min/1.73 m2 or serum creatinine less than 1.5 times ULN corrected for age
- Shortening fraction 27% or higher and/or left ventricular ejection fraction greater than 50% as determined by echocardiography or MUGA
- Able to comply with scheduled follow-up and study procedures
- Written informed consent from parents/legal representative and patient assent when appropriate according to local law
You will not qualify if you...
- Previous cancer-specific treatment for neuroblastoma
- Current use of prohibited medications including corticosteroids within 2 weeks prior to first chemotherapy block and until 1 week after last dinutuximab beta dose except for life-threatening conditions
- Vaccinations including seasonal influenza not allowed during dinutuximab beta administration and until 10 weeks after last dose
- Concomitant use of intravenous immunoglobulins not allowed
- Concomitant use of cardioprotectant dexrazoxane not allowed
- Pregnancy or positive pregnancy test in females of childbearing potential
- Breastfeeding
- Sexually active participants not willing to use highly effective contraception
- Major surgery within 21 days prior to first treatment dose
- History or evidence of severe acute or chronic infection requiring parenteral therapy unless fully healed
- Patients with spinal cord involvement
- Any disease, metabolic or psychological dysfunction, physical or laboratory finding that contraindicates investigational drug use
- Known immediate or delayed hypersensitivity to study drugs
AI-Screening
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Trial Site Locations
Total: 1 location
1
Princess Maxima center for pediatric oncology
Utrecht, Utrecht, Netherlands, 3584 CS
Actively Recruiting
Research Team
J
Jorden Veeneman, PhD
CONTACT
P
Paco Bautista, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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