Study of the use of tasadenoturev for children and young adults with recurrent or resistant high-grade brain tumors

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What is this study about?

This study focuses on patients with high grade malignant brain neoplasm, which is a type of aggressive cancer that grows quickly in the brain. The research specifically looks at cases that are recurrent, meaning the cancer has returned after previous treatment, or refractory, meaning the cancer has not responded to standard therapies. The investigation aims to determine if a single dose of the medication DNX-2401 can cause a response in these tumors.

The treatment involves intratumoral administration, which means the drug tasadenoturev is injected directly into the tumor itself rather than through a vein or a pill. During the study, the medication is delivered into the brain tumor to see how it affects the growth and size of the cancer cells. Participants will be monitored to observe how the tumor reacts to this direct approach.

Who Can Join the Study?

The participant or their parents/guardians must provide written informed consent (a signed document agreeing to join the study), and children must provide assent (their personal agreement to participate) if they are old enough.
Patients who have had an autologous stem cell transplant (a procedure where a patient’s own healthy blood-forming cells are put back into their body) must be at least 3 months past the procedure.
Patients must be fully recovered from any acute toxicities (immediate harmful side effects) caused by previous medical treatments.
Blood tests must show healthy levels of platelets (cells that help blood clot), neutrophils (white blood cells that fight infection), and hemoglobin (a protein in red blood cells that carries oxygen).
Kidney function, measured by creatinine (a waste product in the blood), and liver function must be within normal limits.
Female participants who can become pregnant must have a negative pregnancy test.
Female participants who can become pregnant and are sexually active must use birth control starting at the time of consent and for at least 120 days after receiving the treatment.
Male participants must use birth control starting at the time of consent and for at least 90 days after receiving the treatment.
Patients must have a recurrent (cancer that has returned) or refractory (cancer that does not respond to treatment) high grade malignant brain tumor, meaning an aggressive type of brain cancer.
The tumor must be in a location where gross total resection (complete surgical removal of the tumor) is not possible.
Patients must have a life expectancy of at least 16 weeks at the time they agree to join.
If a tumor returns within an area previously treated with radiation, it must show growth on two MRI (a medical imaging scan) tests, or occur at least 12 weeks after radiation finished, or be confirmed by histopathological (laboratory examination of tissue) testing.
Participants must be between 1 and 25 years of age.
There must be one measurable lesion (a visible tumor area) larger than 10 mm that a doctor believes can be safely reached for a biopsy (taking a small sample of tissue) and the injection of the virus.
Patients must have a certain level of daily functioning, measured by the Lansky Performance Status for those under 16 or the Karnofsky Performance Status for those 16 and older.
Patients must not have received any other chemotherapy (drug treatment for cancer) or immunotherapy (treatment that uses the immune system to fight cancer) in the 4 weeks before joining.
Patients must be off steroids (anti-inflammatory medicines) or have a stable or decreasing dose for at least 2 weeks before treatment.
Patients must not have had radiation therapy (using high-energy rays to kill cancer cells) to the brain, spine, or whole body in the 6 weeks before joining.

Who Cannot Join the Study?

Any medical or psychological condition that could stop you from taking part in the study or from agreeing to join if you are older than 16.
Having received live vaccines (vaccines that use a weakened form of a germ) within 30 days before the treatment or during the study.
Having previously taken part in a study involving experimental viral therapy (treatments using viruses to fight disease).
Being unable to have an MRI scan (a type of medical imaging that uses magnets to look inside the body).
Being pregnant or breastfeeding.
Having a tumor located in the spine or in areas that are unsafe for a stereotactic injection (a precise way of placing a needle into a specific target using computer guidance).
Having tumors that might allow the virus to enter the ventricular system (the fluid-filled spaces in the brain).
Receiving any medical treatments that are not allowed by the study rules.
Having a severe acute infection (a sudden, serious illness caused by germs) or serious problems with the kidneys, liver, heart, or bone marrow (the part of the body that makes blood cells).
Having an immunodeficiency (a weakened immune system) or autoimmune conditions (where the body’s defense system attacks itself).
Having active hepatitis (an infection of the liver) or HIV (a virus that attacks the body’s immune system).
Having another primary malignancy (a different type of original cancer).
A history of encephalitis (swelling of the brain), multiple sclerosis (a disease affecting the nerves), or other CNS infections (infections of the central nervous system, which includes the brain and spine).
Having Li-Fraumeni Syndrome or a genetic defect in the retinoblastoma gene (a gene that helps prevent cancer).
Taking any antiviral drugs (medicines used to treat viruses) or immunosuppressive drugs (medicines that lower the body’s immune response), except for steroids.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country	Status
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.02.2026
The Netherlands	Not yet recruiting	02.02.2026

Trial locations

Tasadenoturev is a therapy that is injected directly into the tumor. It is a type of treatment that uses a modified virus to target and help fight high-grade brain tumors in children and young adults.

Investigated diseases:

Brain neoplasm malignant

High grade malignant brain neoplasm – This is a type of aggressive cancer that starts in the cells of the brain. These tumors are characterized by fast-growing cells that can spread into nearby healthy brain tissue. As the condition progresses, the abnormal cells multiply rapidly and can cause pressure within the skull. The growth of the tumor can disrupt the normal functions of the nervous system. This condition often occurs in forms that are difficult to control due to their rapid development.

Trial ID:

2024-515009-24-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of the use of tasadenoturev for children and young adults with recurrent or resistant high-grade brain tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?