Using dinutuximab beta with chemotherapy to treat high-risk neuroblastoma in children
Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease
This study is testing if a new treatment combining dinutuximab beta with chemotherapy can help children with high-risk neuroblastoma who haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Jagiellonian University Academic / other |
| Drugs / interventions | immunotherapy, dinutuximab, chemotherapy, radiation |
| Locations | 1 site (Krakow, Malopolska) |
| Trial ID | NCT05272371 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and initial efficacy of dinutuximab beta, an anti-GD2 antibody, in combination with various chemotherapy regimens for children with high-risk neuroblastoma that is refractory to standard treatments or has relapsed. The trial aims to recruit 20 patients aged 1-18 years who have not responded to first-line therapies. Participants will receive dinutuximab beta via continuous infusion for five days, alongside chemotherapy agents such as irinotecan, temozolomide, or topotecan. The study is designed to assess the potential for achieving a permanent remission in a population with limited treatment options.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-18 years with high-risk neuroblastoma that is refractory to standard therapy or has relapsed.
Not a fit: Patients with severe toxicities or those who have previously received immunotherapy with dinutuximab beta or other anti-GD2 antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children with high-risk neuroblastoma who have exhausted standard treatment avenues.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in treating neuroblastoma, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG). 2. Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence. 3. Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria). 4. Life expectancy ≥6 months. 5. Obtaining the informed written consent of the patient and/or statutory representative for the treatment. 6. Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding. 7. Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study. Exclusion Criteria: 1. Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders. 2. Patients with neurological toxicities of ≥2 CTCAE WHO grade. 3. Active life-threatening infection until stabilization of the patient's condition. 4. Pregnancy and / or lactation. 5. Sexually active patients who refuse to use an effective method of contraception. 6. Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study. 7. Radiotherapy within 3 weeks prior to the start of the study. 8. Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL). 9. Lack of informed written consent to treatment.
Where this trial is running
Krakow, Malopolska
- University Children Hospital — Krakow, Malopolska, Poland (Recruiting)
Study contacts
- Principal investigator: Walentyna Balwierz, Prof. — Jagiellonian University
- Study coordinator: Walentyna Balwierz, Prof.
- Email: walentyna.balwierz@uj.edu.pl
- Phone: +48 12 333 92 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.