Not yet recruitingRare disease

Study on the Safety and Effectiveness of CEB-01 for Children with Resectable Tumors

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What is this trial about?

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

This clinical trial is focused on studying certain types of childhood cancers, specifically those that can be surgically removed from the abdomen. The cancers being studied include extracranial malignant rhabdoid tumor, desmoplastic small round cell tumor, germ cell tumor, Wilms tumor, synovial sarcoma, high-risk neuroblastoma, soft-tissue sarcoma, and fibrolamellar hepatocellular carcinoma. The treatment being tested is a new formulation called CEB-01, which contains the active substance 7-ethyl-10-hydroxycamptothecin. This substance is delivered through a special material that can be implanted in the body.

The purpose of the study is to evaluate the safety and tolerability of CEB-01 when used alongside standard cancer treatments. The study will involve children from birth to under 18 years of age who have these specific types of tumors. Participants will receive the new treatment in addition to their usual care, and the effects will be compared to those who receive only the standard treatment. The study will monitor for any side effects and how well the treatment works in preventing the cancer from coming back or spreading.

Throughout the study, researchers will collect information on the participants' health and how their bodies process the treatment. This includes measuring the levels of the drug in the blood and observing any changes in the tumors. The study aims to provide valuable information on the potential benefits and risks of using CEB-01 in treating these childhood cancers.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, consent must be provided by the legally authorized guardian. This consent confirms understanding and agreement to participate in the study.
Eligibility is confirmed based on specific criteria, including age, medical condition, and previous treatments.
Step 2
Preparation for treatment
A thorough medical assessment is conducted to ensure adequate liver, kidney, blood, and heart function. This includes blood tests and other necessary evaluations.
A pregnancy test is required for female participants of childbearing potential.
Step 3
Treatment administration
The treatment involves the use of a biocompatible polymeric nanofiber membrane called CEB-01, which contains the active substance 7-ethyl-10-hydroxycamptothecin.
This treatment is administered through implantation during surgery to remove the tumor.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the safety and effectiveness of the treatment. This includes checking for any side effects and assessing the overall health condition.
Progression-free survival, overall survival, and local recurrence-free survival are evaluated. Quality of life is also assessed using a questionnaire.
Step 5
End of trial participation
The trial is expected to continue until April 2029. Participation may end earlier if the treatment is completed or if withdrawal from the study is necessary.
After completing the trial, long-term follow-up may be required to monitor health outcomes.

Who can join the trial?

14 criteria

Participants must be **18 years old or younger**.
Both **female and male participants** who can have children must agree to use reliable birth control during the study and for 6 months after surgery.
Participants must have a **life expectancy of more than 6 months**.
The participant's **legal guardian** must provide written consent for the participant to join the study.
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Participants must have a diagnosis of one of the following:
- **Abdominal soft-tissue sarcoma** (a type of cancer in the soft tissues of the abdomen).
- **High-risk neuroblastoma** (a type of cancer that affects nerve tissue, classified as high risk by the Children's Oncology Group).
- Other specific tumors such as **Wilms tumor**, **germ cell tumor**, **extracranial malignant rhabdoid tumor**, **synovial sarcoma**, **fibrolamellar hepatocellular carcinoma**, and **desmoplastic small round cell tumor**.
- A **histology assessment** (a test to study the tissue) is needed for new cases. For recurring cases, a new test is not needed, but the tumor will be checked to see if it matches the original.
- Participants who have been treated with **irinotecan** (a chemotherapy drug) can join if their disease did not get worse during treatment.
- Participants may have more than one **surgically removable tumor**.
- Participants must have **adequate liver, kidney, blood, and heart function** as shown by specific medical tests.
- Participants must have **recovered from severe side effects** of previous treatments like chemotherapy, immunotherapy, or radiotherapy before joining the trial.
- Participants must have a **Lansky or Karnofsky performance status score of 50 or higher**. This score measures the participant's ability to perform daily activities.
- Female participants who can have children must have a **negative pregnancy test** at the time of screening.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer not listed in the study.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have a medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of certain medical conditions that could interfere with the study.

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Verified sites

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Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain

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Investigated drugs

CEB-01 is a new treatment being tested in this clinical trial. It is a special type of medicine that is made using a biocompatible polymeric nanofiber membrane. This means it is designed to work well with the body and is made up of tiny fibers. The main ingredient in CEB-01 is SN-38, which is a substance that can help fight cancer. In this trial, CEB-01 is being used in addition to the usual treatments that children with certain types of tumors receive. The goal is to see if CEB-01 is safe and if it can help improve the treatment of these tumors in children from birth to less than 18 years old.

7-Ethyl-10-Hydroxycamptothecin

What is already known about the treatment

CEB-01 – CEB-01 is administered as a biocompatible polymeric nanofiber membrane, which is applied directly to the site of the tumor. This medication is currently being studied in clinical trials to evaluate its safety and effectiveness in treating various types of tumors in children, such as extracranial malignant rhabdoid tumor, desmoplastic small round cell tumor, and others. The main therapeutic use of CEB-01 is to treat locally resectable tumors in pediatric patients, in addition to standard care. At the molecular level, CEB-01 works by delivering SN-38, a compound that interferes with the DNA of cancer cells, preventing them from growing and dividing. It is classified pharmacologically as an antineoplastic agent, which means it is used to stop the growth of cancer cells.

Investigated diseases

Extracranial malignant rhabdoid tumour
This is a rare and aggressive type of cancer that typically occurs in soft tissues outside the brain. It often begins in the kidneys but can also develop in other areas of the body. The tumour is characterized by the presence of large, abnormal cells. It tends to grow rapidly and can spread to other parts of the body. The progression involves the invasion of surrounding tissues and potential metastasis to distant organs. It is most commonly diagnosed in young children.
Desmoplastic small round cell tumour
This is a rare and aggressive cancer that primarily affects the abdomen. It is characterized by small, round cancer cells surrounded by dense fibrous tissue. The disease often begins in the peritoneum, the lining of the abdominal cavity. It tends to grow quickly and can spread to other organs within the abdomen. The tumour may also metastasize to distant sites such as the lungs or lymph nodes. It is most commonly found in adolescents and young adults.
Germ cell tumour
These are a group of cancers that originate from germ cells, which are the cells responsible for producing eggs or sperm. They can occur in the ovaries or testes, but also in other areas of the body such as the brain, chest, or abdomen. The progression of germ cell tumours varies depending on their location and type, with some growing slowly and others more rapidly. They can spread to nearby tissues and, in some cases, metastasize to distant organs. Germ cell tumours are most commonly diagnosed in children and young adults.
Wilms tumour
This is a type of kidney cancer that primarily affects children. It usually presents as a large abdominal mass and may cause pain or swelling. The tumour typically grows rapidly and can invade surrounding tissues. It may also spread to other parts of the body, such as the lungs or liver. Wilms tumour is most often diagnosed in children under the age of five. The disease is named after Dr. Max Wilms, who first described it.
Synovial sarcoma
This is a rare type of cancer that occurs in the soft tissues, often near joints such as the knee or ankle. It is characterized by the presence of spindle-shaped cells and can affect both children and adults. The tumour tends to grow slowly but can be aggressive and spread to other parts of the body. It may invade nearby tissues and metastasize to the lungs or lymph nodes. Synovial sarcoma is named for its resemblance to synovial tissue, although it does not originate from it.
High-risk neuroblastoma
This is a cancer that develops from immature nerve cells and primarily affects children. It often begins in the adrenal glands but can also occur in the neck, chest, or spine. The disease is considered high-risk due to its aggressive nature and tendency to spread quickly. It can invade surrounding tissues and metastasize to the bones, liver, or skin. Neuroblastoma is most commonly diagnosed in children under the age of five. The progression involves rapid growth and potential spread to distant sites.