Study on Radiotherapy with Nimotuzumab and Vinorelbine for Newly Diagnosed Childhood and Adolescent Diffuse Intrinsic Pontine Glioma (DIPG) Patients

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What is this study about?

This clinical trial is focused on studying a type of brain tumor called Diffuse Intrinsic Pontine Glioma (DIPG), which primarily affects children and adolescents. The study involves two treatments: nimotuzumab, a monoclonal antibody, and vinorelbine tartrate, a chemotherapy drug. These treatments are given alongside radiotherapy, which uses high-energy rays to target and kill cancer cells. The purpose of the study is to compare the effectiveness of different radiotherapy approaches when used with these medications.

Participants in the study will receive either a combination of radiotherapy, nimotuzumab, and vinorelbine, or a series of radiotherapy sessions with the same medications. The study will observe how well the tumor responds to these treatments over a period of 36 weeks. The goal is to determine which approach provides the best response in shrinking or controlling the tumor.

The study will also monitor other important outcomes, such as the time until the disease progresses, any recurrence of the tumor, the development of any new cancers, and overall survival. This information will help researchers understand the potential benefits and risks of using nimotuzumab and vinorelbine in treating DIPG, and may guide future treatment options for this challenging condition.

1 initial assessment

Eligibility is determined based on age (2 to 21 years), absence of previous treatments except for steroids, and specific medical criteria related to the condition known as diffuse intrinsic pontine glioma (DIPG).

A baseline cranial MRI with gadolinium is required, and a spinal MRI is mandatory due to the possibility of metastatic cases at diagnosis.

2 treatment initiation

The treatment involves radiotherapy combined with two medications: nimotuzumab and vinorelbine tartrate. Both medications are administered as a solution for infusion through an intravenous route.

The study compares two approaches: conventional irradiation and experimental irradiation, with the primary aim of evaluating the best response up to 36 weeks.

3 medication administration

Nimotuzumab and vinorelbine tartrate are administered concomitantly with radiotherapy. The specific dosage and frequency are determined by the study protocol and medical team.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment, including complete and partial responses up to week 36.

Secondary outcomes such as disease progression, recurrence, secondary malignancy, and survival are also evaluated.

5 re-irradiation at relapse

In cases of relapse, re-irradiation may be considered as part of the treatment plan, depending on the study arm and individual patient circumstances.

Who Can Join the Study?

Patients must be between 2 and 21 years old.
No previous treatments are allowed, except for the use of steroids.
Patients must have a specific type of brain tumor called Diffuse Intrinsic Pontine Glioma (DIPG). This is a tumor located in a part of the brain called the pons, and it must show certain characteristics on MRI scans.
Symptoms of the condition must have been present for less than 6 months.
Patients must have a life expectancy of at least 4 weeks.
The Karnofsky/Lansky performance status must be 40% or higher. This is a scale that measures the patient’s ability to perform daily activities.
Patients must not have any organ dysfunction.
Patients must not be pregnant or breastfeeding.
A baseline MRI scan of the brain with a contrast agent called gadolinium is required. If treatment starts more than 2 weeks after this scan, it must be repeated. An MRI of the spine is also required to check for any spread of the disease.
Written and signed informed consent must be obtained from the patient’s parents or legal guardians before starting treatment.
For patients in the observational group with a type of tumor called diffuse midline glioma, the diagnosis must be confirmed by a central review according to standard procedures in Italy.

Who Cannot Join the Study?

Patients who have a different type of brain tumor than Diffuse Intrinsic Pontine Glioma cannot participate. This is a specific type of brain tumor that occurs in a part of the brain called the pons.
Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
Patients who are currently participating in another clinical trial cannot participate, as this might affect the results of the study.
Patients who have had certain treatments recently that might interfere with the study cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Azienda Ospedaliera Santobono Pausilipon	Naples	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Alijdsw Oklzpevekxj Unndbzdqloiut Cethnhtyqznz Dmsaw Sgpgfj E Dnjpj Sujkjey Dt Twupda	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	03.11.2015

Trial locations

Investigated drugs:

Nimotuzumab is a medication used in this trial to help treat a type of brain tumor called diffuse intrinsic pontine glioma (DIPG) in children and adolescents. It is a type of therapy that targets specific proteins on cancer cells, which may help slow down or stop the growth of the tumor.

Vinorelbine is another medication used in the trial. It is a type of chemotherapy that works by interfering with the growth of cancer cells, which can help to shrink the tumor or slow its growth.

Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, radiotherapy is used in combination with the medications to enhance their effectiveness against the tumor.

Re-irradiation is a process where radiotherapy is given again after the initial treatment, especially if the cancer returns or relapses. This approach is being studied to see if it can improve outcomes for patients with DIPG.

Investigated diseases:

Brain stem glioma

Diffuse Intrinsic Pontine Glioma – This is a rare and aggressive brain tumor that primarily affects children. It occurs in the pons, a part of the brainstem, which controls essential functions such as breathing and heart rate. The tumor grows rapidly and infiltrates the surrounding brain tissue, making it difficult to treat. Symptoms often include problems with balance and coordination, difficulty swallowing, and facial weakness. As the disease progresses, these symptoms can worsen, leading to more severe neurological impairments. The condition is challenging to manage due to its location and aggressive nature.

Trial ID:

2024-513654-30-00

Protocol code:

DIPG

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Radiotherapy with Nimotuzumab and Vinorelbine for Newly Diagnosed Childhood and Adolescent Diffuse Intrinsic Pontine Glioma (DIPG) Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?