Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma

Launched by PRINCESS MAXIMA CENTER FOR PEDIATRIC ONCOLOGY · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for children and young adults with high-risk neuroblastoma, a type of cancer that primarily affects young children. The study aims to find the safest and most effective dose of a medication called dinutuximab beta when combined with two standard chemotherapy treatments, known as GPOH and rapid COJEC. Participants will receive dinutuximab beta alongside one of these chemotherapy regimens, with the treatment given over a set number of days at specific intervals.

To be eligible for this trial, patients must be between 18 months and 17 years old, diagnosed with stage M neuroblastoma, and meet certain health criteria, such as having a minimum body weight and normal liver and kidney function. The trial is currently not recruiting participants, but once it starts, families can expect careful monitoring throughout the treatment process. It's important to note that participants cannot have had previous cancer treatments for neuroblastoma or certain other health conditions that would affect their ability to receive these therapies. If you have questions about participation, please consult your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1).
• • 2. Age ≥18 months and \<18 years.
• • 3. Body weight \>12 kg.
• • 4. Alanine transaminase and aspartate aminotransferase \<10 × upper limit of normal (ULN), total bilirubin \<1.5 × ULN based on age specific reference ranges.
• • 5. Calculated glomerular filtration rate \> 60 mL/min/1.73 m2 or serum creatinine \<1.5 × ULN corrected for age.
• • 6. Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) \>50% as determined by echocardiography or MUGA.
• • 7. Able to comply with scheduled follow-up and study procedures.
• • 8. 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 Criteria:
• • 1. Previous cancer-specific treatment for neuroblastoma.
• 2. Current use of a prohibited medication or requires any of these medications during the study:
• • 1. 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.
• • 2. Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course.
• • 3. Concomitant use of intravenous (IV) immunoglobulins is not allowed.
• • 4. Concomitant use of cardioprotectant dexrazoxane is not allowed.
• • 3. Pregnancy or positive pregnancy test in females of childbearing potential.
• • 4. Breast feeding.
• • 5. Sexually active participants not willing to use highly effective contraceptive method
• • 6. Major surgery within 21 days prior to the first treatment dose
• • 7. History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed
• • 8. Patients with spinal cord involvement
• • 9. 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
• • 10. Have a known immediate or delayed hypersensitivity reaction to study drugs