Study of ABTL0812, Irinotecan, and Temozolomide for Children with Relapsed or Refractory Neuroblastoma and Other Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for children with relapsed/refractory neuroblastoma and other solid tumors. Neuroblastoma is a type of cancer that most often affects children and develops from immature nerve cells. The study will explore the use of a medication called ABTL0812, which is taken as a capsule. This medication will be tested both on its own and in combination with other cancer treatments, specifically irinotecan and temozolomide. Irinotecan is given as an injection, while temozolomide is taken as a capsule. These treatments are part of a group of drugs known as chemotherapy, which is used to kill or stop the growth of cancer cells.

The purpose of this study is to determine the best dose of ABTL0812 for children, both when used alone and when combined with other treatments. The study will involve several phases, starting with a small group of participants to find the safest and most effective dose. As the study progresses, more participants will be included to further evaluate the treatment’s effects. Participants will receive the study medication and be monitored by healthcare professionals to assess how well the treatment is working and to identify any side effects.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of their treatment. The study aims to provide valuable information that could lead to better treatment options for children with neuroblastoma and other solid tumors. Participants will be closely observed to ensure their safety and to gather data on how the treatment affects their condition.

1 joining the study

Upon joining the study, the patient must have signed informed consent from themselves, their parents, or legal representatives. The patient should be between 1 and 21 years old and able to swallow capsules.

The patient must have a solid tumor that has progressed, relapsed, or is refractory to at least one standard therapy. There should be at least one measurable site of disease.

2 initial assessment

Before starting the treatment, the patient will undergo an initial assessment to ensure adequate performance status and organ function. This includes blood tests to check hemoglobin levels, white blood cell count, and platelet count.

Renal and liver function will also be assessed. The patient must have normal serum creatinine levels or a creatinine clearance rate above 70 mL/min/1.73m2.

3 treatment phase

The treatment involves the administration of three medications: irinotecan, sodium 2-hydroxylinoleate (known as ABTL0812), and temozolomide.

Irinotecan is given through intravenous perfusion. ABTL0812 and temozolomide are taken orally in capsule form.

The main objective is to define the recommended dose of ABTL0812 when used alone and in combination with chemotherapy.

4 monitoring and evaluation

Throughout the trial, the patient will be monitored for any dose-limiting toxicities, especially during the first cycle of treatment.

Regular follow-ups will be conducted to assess the patient’s response to the treatment and to ensure safety.

5 completion of the trial

The estimated end date for the trial is December 29, 2028. The patient will continue to be monitored until the trial’s completion.

The results will help determine the effectiveness and safety of the treatment regimen for future use.

Who Can Join the Study?

The patient, parents, or legal representatives must sign an informed consent form before any study-specific procedures are done. If the patient is old enough, they should also agree to participate.
The patient must be between 1 and 21 years old at the time of signing the consent form.
The patient must have a body surface area (BSA) of at least 0.5 square meters. BSA is a way to measure the size of the body.
The patient must be able to swallow whole capsules.
The patient must have a solid tumor that has either come back after treatment, not responded to treatment, or for which there is no known cure. It is recommended, but not required, to confirm this with a tissue sample.
The patient must have at least one area of the disease that can be measured or evaluated using specific medical criteria.
The patient must have an adequate performance status, which means they should be able to perform daily activities to a certain extent. For patients under 16 years old, this should be at least 60%. For those 16 years and older, it should be more than 60% on the Karnofsky scale, which measures physical ability.
The patient must have adequate blood, liver, and kidney function, as shown by specific lab tests done within 7 days before starting the study drug. These include:
- Haemoglobin level of at least 8 grams per deciliter (g/dL). Blood transfusions are allowed.
- Peripheral absolute neutrophil count (ANC) of at least 1×10⁹ per liter (L). No support with a medication called G-CSF for 72 hours before starting the study treatment. If using a long-acting form, a 7-day break is needed.
- Platelet count of at least 75×10⁹ per liter (L), without support for 72 hours before starting the study treatment.
- Normal serum creatinine levels based on age and gender. If higher, the creatinine clearance or a special kidney test must be more than 70 milliliters per minute per 1.73 square meters.
- Total bilirubin level of no more than 1.5 times the upper limit of normal (ULN), or up to 3 times ULN if there are liver metastases.
- AST or ALT levels no more than 3 times ULN, or up to 5 times ULN if there are liver metastases. AST and ALT are liver enzymes.
Sexually active males and females of childbearing age must use appropriate contraceptive methods.
Women of childbearing age must have a negative pregnancy test.
The patient must not have any psychological, social, or geographical conditions that could make it difficult to follow the study protocol and schedule.

Who Cannot Join the Study?

Patients who have not experienced a return or worsening of their neuroblastoma or other solid tumors. Neuroblastoma is a type of cancer that usually starts in the nerve tissue of children.
Patients who are not within the age range specified for the study. The study is for certain age groups, so if a patient is too young or too old, they may not be able to participate.
Patients who are not able to take the study medication or the combination of medications being tested. This could be due to allergies or other medical reasons.
Patients who are not able to follow the study procedures or attend the required visits. This could be due to personal or logistical reasons.
Patients who are part of a vulnerable population that the study is not designed to include. This means the study is not suitable for certain groups of people who may need special protection.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Universitario De Cruces	Barakaldo	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Fwumtkkvf Pekz Lc Itnreyjgyzfqp Bbmrvifon Dsa Hywqpwkt Uivwkrvweniwk Lt Ppg	Madrid	Spain
Hqwkqrzl Vosz dxbxnovq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.12.2024

Trial locations

Investigated drugs:

ABTL0812 is an experimental medication being tested in children with relapsed or refractory neuroblastoma and other solid tumors. The trial aims to determine the appropriate dose for children when used alone or in combination with other treatments. ABTL0812 is being studied for its potential to inhibit cancer cell growth and improve treatment outcomes.

Irinotecan is a chemotherapy drug used in this trial in combination with other treatments. It works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading. This medication is often used to treat various types of cancer, including solid tumors.

Temozolomide is another chemotherapy drug included in the trial. It is used to treat certain types of brain tumors and other cancers. Temozolomide works by damaging the DNA of cancer cells, which can lead to their death and help reduce the size of tumors.

Investigated diseases:

Neuroblastoma – Neuroblastoma is a type of cancer that most often affects children and develops from immature nerve cells found in several areas of the body. It commonly arises in and around the adrenal glands, but it can also develop in the abdomen, chest, neck, and near the spine. The disease can spread to other parts of the body, including lymph nodes, bones, bone marrow, liver, and skin. Symptoms may vary depending on the location of the tumor and can include abdominal pain, a lump in the abdomen, or changes in bowel habits. As the disease progresses, it may cause fatigue, loss of appetite, and weight loss. Neuroblastoma can sometimes produce hormones that cause symptoms like high blood pressure, rapid heartbeat, and sweating.

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. Unlike blood cancers, solid tumors are characterized by the growth of abnormal cells that form a lump or mass. The progression of solid tumors depends on their type, location, and growth rate. Symptoms can vary widely and may include pain, swelling, or a noticeable lump. As they grow, solid tumors can interfere with normal body functions and may spread to other parts of the body.

Trial ID:

2023-504246-64-02

Protocol code:

ETNA

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of ABTL0812, Irinotecan, and Temozolomide for Children with Relapsed or Refractory Neuroblastoma and Other Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?