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Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma

ConditionHigh Risk Neuroblastoma
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Dinutuximab Beta

    Biological/Vaccine

    Dinutuximab-beta 10 mg/m²/day administered as a continuous intravenous infusion on Days 0-9 of Cycles 2-6.

  • Induction chemotherapy

    Drug

    Six cycles of standard induction chemotherapy consisting of cyclophosphamide, vincristine, doxorubicin (or epirubicin), etoposide, and cisplatin administered according to the study treatment schedule.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Dinutuximab-Beta with Induction ChemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Unacceptable Toxicities or Toxic Death

Tolerability is assessed by the number of toxic deaths and the number of patients experiencing unacceptable toxicities. Unacceptable toxicities are assessed according to CTCAE criteria and include: 1. toxicity requiring pressors for ≥ 24 hours (e.g., Grade 4 capillary leak syndrome, Grade 4 anaphylaxis/allergic reaction, or Grade 3-4 hypotension), 2. toxicity requiring ventilatory support for \> 24 hours, 3. Grade 4 or unresolved Grade 3 peripheral motor/sensory neuropathy, 4. Grade 4 acute infusion reaction.

Time frame
During Cycles 2-6 of induction therapy (up to approximately 6 months).
2

Clinical Response Rate (RR)

Clinical response rate is defined as the percentage of eligible participants who achieve a Partial Response (PR) or better (e.g., Complete Response or Very Good Partial Response). The tumor response will be evaluated using the revised International Neuroblastoma Response Criteria (INRC).

Time frame
At the end of induction therapy (up to approximately 6 months).

Secondary outcomes

1

Event-Free Survival (EFS)

Event-free survival (EFS) is defined as the time from the date of study enrollment to the occurrence of disease relapse or progression, secondary malignancy, or death.

Time frame
Up to 10 years from the date of study enrollment.
2

Overall Survival (OS)

Overall survival (OS) is defined as the time from the date of study enrollment to death from any cause. Patients without death will be censored at the time of last follow-up.

Time frame
Up to 10 years from the date of study enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

National Taiwan University Hospital

Collaborator

Source ClinicalTrials.gov
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