Not yet recruitingRare disease

A study of RVU120 and everolimus for children with recurrent or progressive medulloblastoma

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on children with medulloblastoma, which is a type of brain tumor. The research specifically involves patients with Group 3 or Group 4 medulloblastoma that has either returned after previous treatment or is continuing to grow. The purpose of the study is to evaluate the safety and the correct dosage of a new treatment combination.

The treatment involves two main medications: RVU120, which is a CDK8 inhibitor, and everolimus. RVU120 is also referred to by its chemical name, SEL120 monohydrochloride. These medications are taken by mouth in the form of capsules or tablets. The study will look at how these drugs work both by themselves and when used together.

During the study, participants will receive these medications to help researchers understand how well the body handles the drugs and to find the maximum dose that can be given safely. The process involves monitoring how the medications move through the body and observing any side effects that may occur during the treatment period.

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
<b>medication administration</b>
You will take sel120 monohydrochloride, which is provided in capsule form. the dose is either 118 mg/m2 (milligrams per square meter of body surface area) or 180 mg/m2, depending on the specific part of the study.
You will also take everolimus, which is provided as a tablet. the dose is 5 mg/m2. this medication is taken by oral use.
Step 2
<b>study objectives and monitoring</b>
The study is designed to evaluate the safety and toxicity of the medications. toxicity refers to the degree of harm or side effects caused by a substance.
The maximum tolerated dose (the highest dose that can be given without causing unacceptable side effects) and the recommended phase 2 dose (the suggested dose for future studies) will be determined through this process.
Health monitoring includes checking for adverse events (side effects), serious adverse events (severe side effects), and dose-limiting toxicities (side effects that are serious enough to prevent a higher dose from being given).

Who can join the trial?

13 criteria

You must have a diagnosis of G3 or G4 medulloblastoma, which is a specific type of brain tumor, that has either returned after previous treatment or is continuing to grow.
Your tumor type must be confirmed using methylation testing, a specialized laboratory test used to identify the specific characteristics of the tumor.
You must be between 3 years old and 18 years old at the time you join the study.
You must be able to swallow pills, such as capsules or tablets.
Your Body Surface Area (BSA), which is a calculation of your body size based on height and weight, must be between 0.4 and 2.5 square meters.
Patients with metastatic disease, meaning the cancer has spread to other parts of the body, are allowed to participate.
You must have fully recovered from any acute toxicities, which are immediate side effects or harmful reactions, caused by previous treatments like chemotherapy, immunotherapy, or radiation therapy.
Your organ function, which refers to how well your vital organs like the liver and kidneys are working, must be healthy.
Your marrow function, which refers to how well your bone marrow produces blood cells, must be healthy.
You must have a stable neurologic status, meaning your brain and nervous system are functioning in a way that meets study requirements.
You must have a certain performance level, measured by the Karnofsky Performance Scale (for those older than 16) or the Lansky Performance Score (for those 16 or younger), which tracks how well you can perform daily activities.
If you are at risk of becoming pregnant or fathering a child, you must agree to use an acceptable form of birth control during the study.
You or your parent/guardian must be able to understand the study details and provide informed consent, which is a written agreement to participate.

Who cannot join the trial?

7 criteria

You cannot participate if you are pregnant or breastfeeding, and individuals who could become pregnant must have a blood test to confirm they are not pregnant before joining.
You are excluded if you have any other serious health problems, such as severe infections or issues with your heart (cardiac), lungs (pulmonary), liver (hepatic), or other organs, that might make it unsafe for you to take the study medicine.
You cannot join if you are currently receiving other medical therapies (treatments) at the same time.
You are excluded if you have had any major surgery, including a tumor biopsy (a procedure where a small piece of a tumor is removed to be examined), within the last 14 days.
You cannot participate if you have malabsorption (a condition where the body has trouble absorbing nutrients or medicine from the digestive tract) or if you have had a large part of your stomach or bowels removed that would prevent the medicine from working correctly.
You are excluded if you have previously used a CDK8 inhibitor or an mTOR inhibitor (types of medicines that block specific proteins in the body, such as everolimus, sirolimus, or temsirolimus).
You cannot join if the doctor believes you are unable or unwilling to attend all follow-up visits (scheduled appointments to check your progress) or if you cannot follow the rules for taking the medicine and completing required tests to monitor for toxicity (harmful side effects caused by a drug).

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Verified sites

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Instytut Pomnik Centrum Zdrowia Dziecka
Verified
Warsaw, Poland

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Investigated drugs

SEL120
is an experimental medication taken by mouth in capsule form. It belongs to a class of drugs known as CDK8 inhibitors, which are designed to work by interfering with specific proteins in cells that help them grow and divide.
Everolimus
is a medication taken by mouth in tablet form. It is used to help slow down the growth of certain types of cancer cells by targeting specific pathways that allow cells to multiply.

What is already known about the treatment

SEL120 monohydrochloride
This medication is taken by mouth in the form of a capsule. Currently being studied in clinical trials, it is classified as a CDK8 inhibitor used to treat certain types of brain tumors. It works at the molecular level by blocking a specific protein that helps cancer cells grow and divide.
Everolimus
This medicine is administered orally in the form of a tablet. It is an established drug used to treat various cancers and conditions related to cell growth. It functions as a protein inhibitor that blocks a specific pathway within cells, effectively stopping the signals that tell cancer cells to multiply.

Investigated diseases

Medulloblastoma - This is a type of tumor that starts in the cerebellum, which is the part of the brain responsible for balance and coordination. It is a fast-growing cancer that often affects children. The disease can involve different molecular groups that influence how the tumor behaves. As it progresses, the tumor can grow larger or spread to other areas of the brain and spinal cord. It may also show changes in specific gene expressions.