Study on Dinutuximab Beta and Chemotherapy for Patients with Neuroblastoma Resistant to Standard Treatment or with Relapsed Disease

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What is this study about?

This clinical trial is focused on studying a type of cancer called neuroblastoma, which can be difficult to treat with standard therapies. Neuroblastoma is a cancer that most often affects children and develops from immature nerve cells. The study is exploring a treatment that combines a medication called dinutuximab beta with chemotherapy. Dinutuximab beta is a type of immunotherapy, which means it helps the body’s immune system fight cancer.

The purpose of the study is to evaluate the safety of this combined treatment in patients whose neuroblastoma has either returned after treatment, continued to grow despite treatment, or did not respond to initial treatments. The study will involve 20 patients who will receive the combination of dinutuximab beta and chemotherapy. Their results will be compared to historical data from two groups of patients: one group that received only chemotherapy and another that received only immunotherapy.

Participants in the study will receive the treatment over a period of time, and researchers will monitor them for any side effects or reactions. The study aims to understand how safe and effective the combination of dinutuximab beta and chemotherapy is for treating neuroblastoma that is resistant to standard treatments. This research could provide valuable insights into new ways to manage this challenging disease.

1 joining the study

Upon joining the study, the patient is diagnosed with neuroblastoma that is either recurrent, progressing, or resistant to initial treatment.

The patient is between 1 and 18 years old and has a life expectancy of at least 6 months.

Vital organs must function adequately, with any dysfunction being below a certain severity level.

2 treatment initiation

The patient begins treatment with dinutuximab beta, a medication administered through an infusion.

This medication is part of a combination therapy with chemotherapy, specifically designed for patients with neuroblastoma that has not responded to standard treatments.

3 treatment cycles

The treatment is administered in cycles, with the primary goal of evaluating the safety of the combination therapy.

The study monitors various potential side effects, including allergic reactions, neurological issues, and organ impairments.

4 monitoring and evaluation

Throughout the treatment, the patient is closely monitored for any side effects or complications.

The study aims to assess the number of treatment cycles that are interrupted or stopped due to side effects.

5 completion of study

The study is expected to conclude by the end of 2026.

The results will contribute to understanding the safety and effectiveness of the combination therapy for neuroblastoma.

Who Can Join the Study?

The patient must have a diagnosis of neuroblastoma (NBL) according to international criteria. Neuroblastoma is a type of cancer that usually affects children.
The patient should be between 1 and 18 years old and have high-risk neuroblastoma (HR-NBL) that is either not responding to initial treatment, getting worse, or has come back after treatment.
The patient must have vital organs that are working well enough. If there are any problems, they should not be severe, specifically below grade 4 according to a classification system used by doctors to describe side effects.
The patient should have a life expectancy of at least 6 months.
Both male and female patients are eligible to participate.

Who Cannot Join the Study?

Patients who have not experienced a return or worsening of their neuroblastoma condition. Neuroblastoma is a type of cancer that usually affects children and develops from immature nerve cells.
Patients who have not shown resistance to the first treatment they received for neuroblastoma.
Patients who are not within the specified age range for the study. The study is looking for participants who are at least 2 years old.
Patients who do not meet the gender criteria, as the study includes both male and female participants.
Patients who are not considered part of a vulnerable population. A vulnerable population includes groups who may have a higher risk of harm or exploitation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Dzieciecy W Krakowie	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

Dinutuximab Beta

Dinutuximab beta is an immunotherapy medication used in this trial. It is designed to help the body’s immune system target and destroy cancer cells. In this study, it is combined with chemotherapy to treat patients with neuroblastoma, a type of cancer that affects nerve tissue. The goal is to see if this combination is safe and effective for patients whose cancer has not responded to standard treatments or has returned after treatment.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used alongside dinutuximab beta to treat neuroblastoma. The study aims to compare the safety and effectiveness of this combination therapy with historical data from patients who received only chemotherapy or only immunotherapy.

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children and develops from immature nerve cells found in several areas of the body. It typically begins in the adrenal glands, but can also develop in the neck, chest, abdomen, or spine. The disease can be aggressive and may spread to other parts of the body, such as the bones, liver, and skin. Symptoms vary depending on the location of the tumor and may include abdominal pain, a lump in the abdomen, or changes in bowel habits. As the disease progresses, it can cause fatigue, loss of appetite, and weight loss. Neuroblastoma is often diagnosed at an advanced stage, which can complicate treatment and management.

Trial ID:

2024-513141-37-00

Protocol code:

ChIm-NB-PL

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dinutuximab Beta and Chemotherapy for Patients with Neuroblastoma Resistant to Standard Treatment or with Relapsed Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?