What side effects are associated with this type of intervention?

Treatments for neuroblastoma, such as naxitamab (an anti-GD2 monoclonal antibody) and ceritinib (an ALK inhibitor), commonly cause side effects including pain, fever, allergic reactions, hypotension, capillary leak syndrome, and peripheral neuropathy. Additionally, gastrointestinal issues like diarrhea, nausea, and vomiting, liver enzyme abnormalities, fatigue, and potential cardiac effects such as QT prolongation are also observed.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroblastoma, particularly focusing on monoclonal antibodies and ALK inhibitors. Dinutuximab, an anti-GD2 monoclonal antibody, was approved for high-risk Neuroblastoma and works similarly to Naxitamab by targeting GD2 on neuroblastoma cells. Additionally, Crizotinib, an ALK inhibitor, has been used in cases of Neuroblastoma with ALK mutations, similar to Ceritinib. These approvals highlight the ongoing efforts to target specific molecular pathways in Neuroblastoma treatment.

What other types of research exist?

Promising novel alternatives for Neuroblastoma treatment in 2024 include Lorlatinib, a next-generation ALK inhibitor, and Dinutuximab, another anti-GD2 monoclonal antibody. Additionally, emerging therapies such as GD2-CAR T-cell therapy and novel combinations of targeted agents and immunotherapies are being actively investigated and may offer new treatment options.

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Monoclonal Antibodies

Naxitamab for High-Risk Neuroblastoma

Phase 2

Recruiting

Research Sponsored by Giselle Sholler

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 7

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing naxitamab with standard chemotherapy for high-risk neuroblastoma. Patients with a specific genetic change will also receive ceritinib. Naxitamab helps the immune system attack cancer, and ceritinib stops cancer cell growth. The goal is to improve survival rates for these patients.

Who is the study for?

This trial is for children and young adults up to 21 years old with newly diagnosed high-risk neuroblastoma. Participants must have certain types of the disease, good liver and kidney function, and not be pregnant or breastfeeding. They should agree to use effective contraception if applicable. Those who've had previous systemic therapy beyond one cycle or are on immunosuppressants may not qualify.

What is being tested?

The study tests adding naxitamab to standard chemotherapy during the first five cycles of treatment for neuroblastoma. For patients with an ALK mutation, ceritinib will also be included once test results are available. The goal is to see if this combination improves response rates and survival compared to standard therapy alone.

What are the potential side effects?

Potential side effects include reactions related to infusion such as fever or chills, pain at tumor sites due to inflammation caused by immune response, changes in blood pressure, allergic reactions, bone marrow suppression leading to low blood cell counts which can increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with a Very Good Partial Response (VGPR)(+) rate (VGPR + Complete Response (CR) rate)

Secondary study objectives

Number of days that subjects remain alive

Number of days that subjects remain in remission

Objective Response Rate (ORR)

+2 more

Other study objectives

Morphine equivalent daily dose (MEDD) per subject

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Subjects with ALK aberrationExperimental Treatment2 Interventions

5 cycles of standard of care induction + naxitimab + ceritinib Naxitimab on Days 1, 3, and 5 of each cycle Ceritinib once daily on every day of study

Group II: Subjects with ALK Wildtype or UnknownExperimental Treatment1 Intervention

5 cycles of standard of care induction + naxitimab Naxitimab on Days 1, 3, and 5 of each cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ceritinib

2013

Completed Phase 3

~1030

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Naxitamab, an anti-GD2 monoclonal antibody, targets the GD2 antigen present on Neuroblastoma cells, leading to the destruction of these cancer cells by the immune system. This targeted approach helps in minimizing damage to healthy cells, thereby reducing side effects. Ceritinib, an ALK inhibitor, blocks the activity of the ALK protein, which is often mutated and overactive in Neuroblastoma, leading to uncontrolled cell growth. By inhibiting ALK, Ceritinib helps to halt the proliferation of cancer cells. These mechanisms are crucial for Neuroblastoma patients as they offer more precise and effective treatment options, potentially improving outcomes and reducing the burden of side effects compared to traditional chemotherapy.

The importance of phase I/II trials in pediatric oncology.Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1, or ALK aberrations (STARTRK-NG).Opportunities and Challenges in Drug Development for Pediatric Cancers.