Recruiting

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

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of study medication
A single dose of tasadenoturev (also known as dnx-2401) is administered directly into the tumor, which is the area of abnormal cell growth in the brain. this method of delivery is called intratumoral administration.
The amount of tasadenoturev provided in this single dose is 5x10¹⁰ viral particles.
Step 2
Monitoring and evaluation
The response of the tumor to the medication is monitored. this includes checking for a complete response (the tumor disappears), a partial response (the tumor shrinks), or stable disease (the tumor does not grow for at least 12 weeks).
Any adverse events, which are side effects or medical problems, are recorded during the first 12 weeks following the administration of the medication.
The time it takes for a response to occur and how long that response lasts are tracked.
The progression-free survival (the length of time during and after treatment that the disease does not get worse) and overall survival (the length of time from the start of the trial that patients remain alive) are measured at 6-month and 12-month intervals.
Measures regarding physical function, daily activities, and quality of life are compared to the initial status at the start of the study.

Who can join the trial?

18 criteria

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 trial?

15 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Universitario De Navarra
Pamplona, Spain
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Tasadenoturev - This medication is an experimental therapy administered by injecting it directly into a tumor. It is currently being studied in clinical trials to see if it can effectively treat aggressive brain tumors that have returned or have not responded to other treatments. This substance belongs to a class of drugs known as oncolytic viruses, which work by specifically targeting and infecting cancer cells to cause them to burst and die. By destroying the cancer cells from within, it also helps the body's immune system recognize and attack the remaining tumor cells.

Investigated diseases

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.