Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma
ConditionHigh Risk Neuroblastoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-30
SponsorChang Gung Memorial Hospital
About this trial
This clinical trial investigates the safety, side effects, and effectiveness of combining an immunotherapy drug called dinutuximab-beta with standard induction chemotherapy for patients newly diagnosed with high-risk neuroblastoma. Dinutuximab-beta is an antibody designed to target specific molecules on the surface of neuroblastoma cells.
In this pilot study, enrolled patients will receive dinutuximab-beta as a continuous intravenous infusion alongside a standard 6-cycle induction chemotherapy regimen. The primary goals of this study are to monitor how well patients tolerate the new combination treatment closely and to determine how effectively tumors shrink before patients proceed to the next phase of their standard consolidation therapy.
Eligibility criteria
Qualifiers
Must be 1 to 30 years of age at the time of initial diagnosis.
Must have histological verification of neuroblastoma or ganglioneuroblastoma, OR demonstration of neuroblastoma cells in the bone marrow with elevated urinary VMA at the time of initial diagnosis.
INRG Stage M: MYCN amplification (> 4-fold increase), OR age 12 to < 18 months without MYCN amplification but with unfavorable histology/DI = 1/SCA, OR age > 18 months regardless of biologic features.
INRG Stage MS: MYCN amplification, OR age 12 to < 18 months without MYCN amplification but with unfavorable histology/DI = 1/SCA.
Disqualifiers
Participation in other interventional clinical trials within 1 month.
Inability to obey the trial instructions.
Patients with bone marrow failure syndromes.
Current requirement for immunosuppressive medications (e.g., tacrolimus, cyclosporine, systemic corticosteroids for reasons other than prevention/treatment of acute allergic reactions or adrenal replacement therapy).
Trial design
Treatments tested in this trial
- Dinutuximab Beta
- Induction chemotherapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Chang Gung Memorial Hospital
Lead sponsor
National Taiwan University Hospital
Collaborator
Source ClinicalTrials.gov