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Study to Find the Right Dose and Safety of Lutetium (177Lu) Edotreotide and Arginine-Lysine in Children with Somatostatin Receptor-Positive Tumors

Verified siteInvestigationalNo placebo
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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 the treatment of children with somatostatin receptor-positive tumors, which are a type of solid tumor or lymphoma that shows a specific marker called the somatostatin receptor. These tumors can include various types such as neuroendocrine tumors, lymphoma, and central nervous system tumors. The treatment being tested is called lutetium Lu 177 edotreotide, a targeted radiopharmaceutical therapy. This therapy involves using a radioactive substance to target and treat the tumors. Additionally, an arginine-lysine solution is used to support the treatment process.

The purpose of the study is to determine the appropriate dose of lutetium Lu 177 edotreotide for children, based on its safety and how it moves through the body. The study will involve giving the treatment to participants and monitoring them to see how their bodies respond. This includes checking for any side effects and measuring how the treatment is absorbed by the body. The study will also look at how effective the treatment is in reducing the size of the tumors.

Participants in the study will receive the treatment through an intravenous infusion, which means it will be given directly into a vein. The study will take place over several cycles, with regular check-ups to monitor the participants' health and the progress of the treatment. The goal is to find the safest and most effective dose for treating these types of tumors in children. The study is expected to continue for several years to gather enough information to make informed decisions about the treatment's use in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and previous treatments.

    Imaging tests such as CT or MRI scans are conducted to evaluate the tumor and confirm it is somatostatin receptor-positive (SSTR-positive).

  2. Step 2

    Pre-treatment preparation

    Before starting the treatment, a washout period is required if prior therapies were received. This ensures that previous treatments do not interfere with the trial.

    A heart function test is performed if there was previous exposure to certain cancer treatments.

  3. Step 3

    Treatment administration

    The treatment involves the administration of 177Lu-Edotreotide through an intravenous infusion. This is a targeted radiopharmaceutical therapy designed to treat SSTR-positive tumors.

    An Arginine-Lysine solution is also administered intravenously to protect the kidneys during the treatment.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to the treatment. This includes imaging tests and blood tests to measure radioactivity levels.

    The treatment's effects on the body are evaluated, focusing on safety and any side effects experienced.

  5. Step 5

    Dose evaluation

    The appropriate dose of 177Lu-Edotreotide is determined based on safety and how the body processes the drug.

    The goal is to find the highest dose that is safe and effective, with minimal side effects.

  6. Step 6

    End of trial

    The trial concludes with a final assessment to evaluate the overall response to the treatment.

    Long-term follow-up may be required to monitor the patient's health and any lasting effects of the treatment.

Who can join the trial?

10 criteria

  • The child must be at least 2 years old and younger than 18 years old at the time of joining the trial.
  • The child must have a confirmed diagnosis of a tumor that is positive for **somatostatin receptors (SSTR)**. This includes various types of tumors such as neuroendocrine tumors, central nervous system tumors, lymphoma, and others.
  • The tumor must have come back or not responded to at least one previous treatment.
  • The child must have a **Karnofsky score** of 50% or higher if they are older than 16 years, or a **Lansky score** of 50% or higher if they are 16 years or younger. These scores measure the child's ability to perform daily activities.
  • The child must have recovered from any side effects of previous treatments, except for hair loss or stable conditions that are being treated, like certain electrolyte imbalances or hypothyroidism.
  • If the child has had certain treatments before, like **anthracyclines** or chest radiation, their heart function must be checked and show an **ejection fraction** of 55% or higher. This is a measure of how well the heart is pumping blood.
  • The child must have a positive result for SSTR expression confirmed by a test called **immunohistochemistry (IHC)** on a tumor sample.
  • The child must have a scan showing that the tumor takes up more radioactivity than the liver. This scan must be done within two months before joining the trial.
  • The child must have a **CT or MRI** scan of the tumor and any spread areas within two months before joining the trial. All important tumor areas must be SSTR-positive.
  • Written consent must be obtained from the child's parent(s) or legal guardian(s), and the child must agree to participate, following local rules.

Who cannot join the trial?

7 criteria

  • Patients who are not at least two years old.
  • Patients who do not have a type of tumor or lymphoma that is **SSTR-positive**. This means the tumor does not have certain receptors that the treatment targets.
  • Patients who have not tried at least one other treatment before.
  • Patients who are not able to safely receive the study treatment based on their health condition.
  • Patients who are pregnant or breastfeeding.
  • Patients who have other medical conditions that might interfere with the study treatment.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Lutetium Lu 177 Edotreotide is a targeted radiopharmaceutical therapy used in this trial. It is designed to treat tumors that have somatostatin receptors, which are often found in certain types of cancer. This therapy works by delivering radiation directly to the tumor cells, helping to destroy them while minimizing damage to surrounding healthy tissue. The trial aims to determine the appropriate dosage for children, focusing on the safety and how the body processes the therapy.

What is already known about the treatment

Lutetium Lu 177 Edotreotide – This medication is administered as a targeted radiopharmaceutical therapy, typically through intravenous injection. It is currently being studied in clinical trials, particularly for its use in pediatric patients with somatostatin receptor-positive solid tumors or lymphoma that have not responded to previous treatments. The main therapeutic indication is for tumors that express somatostatin receptors, allowing the drug to bind specifically to these receptors and deliver targeted radiation to the cancer cells. At the molecular level, it works by attaching to somatostatin receptors on tumor cells, delivering radiation directly to the cancer, thereby minimizing damage to surrounding healthy tissue. It is classified as a radiopharmaceutical, a type of drug that combines a radioactive component with a molecule that targets specific cells.

Investigated diseases

  • Somatostatin Receptor Positive Solid Tumors

    These are a group of tumors that have receptors for the hormone somatostatin on their surface. They can occur in various parts of the body and are characterized by their ability to bind to somatostatin, which can influence their growth. These tumors may not respond to standard treatments and can recur after initial therapy. They are often monitored using imaging techniques to assess their progression. The presence of somatostatin receptors can sometimes be used to target specific therapies. These tumors are considered rare, especially in pediatric patients.

  • Lymphoma

    Lymphoma is a type of cancer that begins in the lymphatic system, which is part of the body's immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors in lymph nodes and other parts of the body. Lymphoma can be classified into Hodgkin and non-Hodgkin types, each with different characteristics and progression patterns. It can cause symptoms such as swollen lymph nodes, fever, and weight loss. The disease can be recurrent or refractory, meaning it may return after treatment or not respond to standard therapies. Monitoring and imaging are crucial for assessing the disease's progression and response to treatment.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2024-512831-66-00Protocol codeITM-1191-01Estimated enrolment26 patientsSponsorITM Solucin GmbH

sourced from the EU Clinical Trials Register and site verification

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