Status:
RECRUITING
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Lead Sponsor:
Princess Maxima Center for Pediatric Oncology
Collaborating Sponsors:
EUSA Pharma, Inc.
Conditions:
Neuroblastoma
Eligibility:
All Genders
18-18 years
Phase:
PHASE1
Brief 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 hi...
Detailed Description
This study is a multicenter, open-label, dual-cohort, Phase 1 study of DB combined with each of 2 different induction chemotherapy regimens in 2 cohorts. When the recommended cumulative DB dose level ...
Eligibility Criteria
Inclusion
- Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1).
- Age ≥18 months and \<18 years.
- Body weight \>12 kg.
- Alanine transaminase and aspartate aminotransferase \<10 × upper limit of normal (ULN), total bilirubin \<1.5 × ULN based on age specific reference ranges.
- Calculated glomerular filtration rate \> 60 mL/min/1.73 m2 or serum creatinine \<1.5 × ULN corrected for age.
- Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) \>50% as determined by echocardiography or MUGA.
- Able to comply with scheduled follow-up and study procedures.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national law and legislation.
Exclusion
- Previous cancer-specific treatment for neuroblastoma.
- Current use of a prohibited medication or requires any of these medications during the study:
- Treatment with corticosteroids is not allowed within 2 weeks prior to the first block of chemotherapy and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
- Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course.
- Concomitant use of intravenous (IV) immunoglobulins is not allowed.
- Concomitant use of cardioprotectant dexrazoxane is not allowed.
- Pregnancy or positive pregnancy test in females of childbearing potential.
- Breast feeding.
- Sexually active participants not willing to use highly effective contraceptive method
- Major surgery within 21 days prior to the first treatment dose
- History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed
- Patients with spinal cord involvement
- Any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
- Have a known immediate or delayed hypersensitivity reaction to study drugs
Key Trial Info
Start Date :
January 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06485947
Start Date
January 28 2025
End Date
December 1 2031
Last Update
July 8 2025
Active Locations (1)
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1
Princess Maxima center for pediatric oncology
Utrecht, Utrecht, Netherlands, 3584 CS