Phase Ib study combining dinutuximab beta with induction chemotherapy regimens in patients with newly diagnosed high-risk neuroblastoma

Phase 1

• Conditions: euroblastoma; MedDRA version: 21.0Level: LLTClassification code: 10008126Term: Cerebral neuroblastoma Class: 10029104; MedDRA version: 21.1Level: PTClassification code: 10073130Term: Central nervous system neuroblastoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10029260Term: Neuroblastoma Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-509673-22-00
• Lead Sponsor: Prinses Maxima Centrum voor Kinderoncologie B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria, Age =18 months and <18 years, Body weight >12 kg., Alanine transaminase (ALT) and aspartate aminotransferase (AST) <10 × upper limit of normal (ULN), total bilirubin <1.5 × ULN based on age specific reference ranges, Calculated glomerular filtration rate (based on Schwartz formula; section 10.4.7) >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 Criteria

Previous cancer-specific treatment for neuroblastoma, 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 or places the patient at unacceptable risk from treatment complications., Patients with pre-existing grade 3-4 neurological toxicity., Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including conventional chemotherapeutics and dinutuximab beta., Current use of a prohibited medication or requires any of these medications during the study (See Section 8.1.2 for details): a. Treatment with corticosteroids is not allowed within 2 weeks prior to the first treatment course and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions. b. Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course. c. Concomitant use of intravenous (IV) immunoglobulins is not allowed. d. Concomitant use of cardioprotectant dexrazoxane is not allowed., Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within 7 days prior to C1D1, Breast feeding, Sexually active participants not willing to use highly effective contraceptive method (pearl index <1) as defined in CTFG HMA 2020 (Appendix 2) during trial participation and until 6 months after end of protocol therapy, Major surgery within 21 days prior to enrollment of the first treatment dose (open tumor biopsy or central line placement is not considered major surgery)., History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed (Grade <1) at least 4 weeks prior to start of treatment, Patients with spinal cord involvement (symptomatic patients or if identified on imaging done to establish the diagnosis; there is no screening for spinal cord involvement for all patients).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified