Study on the Safety and Efficacy of AloCelyvir for Children, Adolescents, and Young Adults with Diffuse Intrinsic Pontine Glioma or Medulloblastoma.

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What is this study about?

This clinical trial is focused on studying two types of brain tumors in young patients: Diffuse Intrinsic Pontine Glioma (DIPG) and Medulloblastoma. DIPG is a rare and aggressive brain tumor found in the brainstem, while Medulloblastoma is a cancerous brain tumor that can occur in the cerebellum. The treatment being tested in this study is called AloCelyvir, which is a special type of cell therapy. It involves using cells from bone marrow that have been modified with a virus called ICOVIR-5 to potentially help fight the cancer.

The purpose of the study is to evaluate the safety and effectiveness of AloCelyvir in treating these conditions. For patients with newly diagnosed DIPG, the study will test the combination of AloCelyvir with radiotherapy, which is a treatment that uses high-energy rays to target and kill cancer cells. For those with Medulloblastoma that has returned or worsened, the study will test AloCelyvir on its own. Participants will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein.

The study will involve regular visits to monitor the participants’ health and response to the treatment. The goal is to understand how well the treatment works and to ensure it is safe for use in children, adolescents, and young adults. The trial will also look at how the body reacts to the treatment over time, including any side effects that may occur. This research aims to provide new insights into potential treatments for these challenging brain tumors.

1 initial assessment

Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

A physical examination and various tests are performed to ensure all criteria are met for participation in the study.

2 treatment plan discussion

The treatment plan is explained, including the use of AloCelyvir, a medication administered through an intravenous infusion.

The purpose of the trial, which is to assess the safety and effectiveness of AloCelyvir in combination with radiotherapy for certain conditions, is discussed.

3 medication administration

AloCelyvir is administered as a dispersion for infusion. The dosage and frequency are determined based on individual health needs and the specific protocol of the trial.

The duration of administration is specified according to the trial’s requirements, and patients are monitored closely during this period.

4 ongoing monitoring

Regular visits are scheduled to monitor health and response to the treatment. This includes physical exams, blood tests, and other necessary assessments.

Any side effects or changes in health are documented and addressed promptly.

5 final evaluation

At the end of the treatment period, a comprehensive evaluation is conducted to assess the overall impact of the treatment.

The results are compared to initial assessments to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

Patients must be between 1 and 21 years old.
Patients should not have received previous treatment with radiotherapy (radiation treatment) or chemotherapy (cancer treatment using drugs).
Patients must be able to receive radiotherapy.
For patients with relapsed or refractory medulloblastoma (a type of brain tumor), they must have already tried surgery, radiation therapy, and chemotherapy, and these treatments must not have worked.
Patients must have recovered from the side effects of previous treatments to a mild level, except for hearing loss, hair loss, and nerve damage.
A written informed consent must be signed by the patient’s legal representative, and if the patient is 12 years or older, they must also sign.
The disease must be measurable or evaluable according to specific medical criteria.
Patients must have appropriate functional status and organ function, including:
- Functional status of at least 50% (patients using a wheelchair due to tumor-related paralysis are considered as outpatients).
- Platelet count of at least 75,000/µL without support for 3 days.
- Absolute neutrophil count (ANC) of at least 500/µL without growth factor for 3 days.
- Hemoglobin level of at least 8 g/dL (transfusion allowed).
- Kidney function with a glomerular filtration rate (GFR) greater than 60 mL/min/1.73 m².
- Total bilirubin level of 1.5 times the upper limit of normal (ULN) or less.
- Liver enzymes (GOT and GPT) levels of 3 times the ULN or less, or 5 times ULN for patients with liver metastasis.
Patients must be able to comply with the treatment and schedule of visits and assessments.
Patients must have a life expectancy of at least 8 weeks.
Sexually active males and females of childbearing age must use highly effective contraceptive methods.
Females of childbearing age must have a highly sensitive negative pregnancy test in blood or urine.
For patients with a new diagnosis of DIPG (a type of brain tumor), the diagnosis can be clinical, radiological, or histological if a biopsy was performed before joining the study.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) or Medulloblastoma that is worsening or coming back cannot participate.
Patients who are not children, adolescents, or young adults are not eligible.
Patients who are not able to receive the combination of AloCelyvir and radiotherapy safely cannot join the study.
Patients who cannot safely receive AloCelyvir alone are excluded.
Patients who are not male or female are not eligible.
Patients who are not considered part of a vulnerable population cannot participate.

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	12.07.2021

Trial locations

Investigated drugs:

Allogenic Bone Marrow-Derived Mesenchymal Stem Cells Transduced With Icovir-5, Ex Vivo Expanded

AloCELYVIR is a treatment that combines special cells called mesenchymal allogenic cells with a virus known as ICOVIR-5. This combination is being tested to see if it can help treat certain types of brain tumors in children, adolescents, and young adults. The treatment is being studied in two ways: one, in combination with radiotherapy for a type of brain tumor called diffuse intrinsic pontine glioma (DIPG), and two, as a standalone treatment for another type of brain tumor called medulloblastoma when it comes back or gets worse.

Radiotherapy is a treatment that uses high-energy rays, like X-rays, to target and kill cancer cells. In this trial, radiotherapy is used alongside AloCELYVIR to see if the combination is safe and effective for treating newly diagnosed DIPG, a type of brain tumor. The goal is to see if this combination can help control the tumor better than using radiotherapy alone.

Investigated diseases:

Medulloblastoma recurrent

Diffuse Intrinsic Pontine Glioma (DIPG) – This is a type of brain tumor that occurs in the pons, a part of the brainstem. It primarily affects children and is characterized by its rapid growth. The tumor infiltrates the surrounding brain tissue, making it difficult to remove surgically. As it progresses, it can interfere with essential bodily functions controlled by the brainstem, such as breathing, heart rate, and motor skills. Symptoms often include problems with balance, coordination, and facial movements. The disease typically advances quickly, affecting the patient’s neurological functions.

Medulloblastoma – This is a malignant brain tumor that originates in the cerebellum or posterior fossa. It is most commonly diagnosed in children but can also occur in adolescents and young adults. The tumor tends to grow rapidly and can spread to other parts of the brain and spinal cord through cerebrospinal fluid. As it progresses, it can cause increased intracranial pressure, leading to headaches, nausea, and vomiting. Other symptoms may include problems with balance, coordination, and changes in behavior or personality. The disease’s progression can significantly impact neurological and cognitive functions.

Trial ID:

2022-502516-37-00

Protocol code:

FIBHNJ-2020-01

NCT ID:

NCT04758533

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Efficacy of AloCelyvir for Children, Adolescents, and Young Adults with Diffuse Intrinsic Pontine Glioma or Medulloblastoma.

What is this study about?

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