Recruiting

Study of Lutetium (177Lu) Oxodotreotide for Children with Relapsed or Refractory High-Risk Neuroblastoma

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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 a type of cancer called neuroblastoma, which primarily affects children. The trial is investigating a treatment using a medication called 177Lutetium-DOTATATE. This medication is given as a solution through an infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to confirm the appropriate dose and assess how well this treatment works in children whose neuroblastoma has either returned after treatment or has not responded to previous treatments.

Participants in the study will receive the 177Lutetium-DOTATATE treatment, and their response to the medication will be monitored over time. The study will also involve the use of imaging techniques, such as PET/CT scans, to observe changes in the cancer. These scans help doctors see how the treatment is affecting the cancer cells. The study will take place over several months, with regular check-ups to monitor the health and progress of the participants.

In addition to the main treatment, some participants may receive other supportive medications, such as LysaKare, which contains substances like L-lysine hydrochloride and L-arginine hydrochloride. These are used to help protect the kidneys during the treatment. The study aims to gather information on the effectiveness and safety of the treatment, as well as its impact on the participants' overall health and survival. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

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, you will receive detailed information about the study and what to expect. You will be asked to provide written informed consent, which means you agree to participate after understanding the trial's purpose and procedures.
Step 2
Initial assessment
Before starting the treatment, a series of tests will be conducted to confirm your eligibility. These tests include imaging scans and laboratory tests to assess your current health status and ensure you meet the trial's requirements.
Step 3
Treatment administration
The treatment involves the administration of 177Lutetium-DOTATATE, which is given as a solution for infusion through a vein. This is done in a controlled medical setting to ensure your safety.
You will also receive LysaKare, a solution for infusion, to help protect your kidneys during the treatment. This is administered intravenously as well.
Step 4
Monitoring and follow-up
After the treatment, regular follow-up visits will be scheduled to monitor your response to the therapy. This includes imaging tests and blood tests to evaluate the effectiveness of the treatment and check for any side effects.
The primary assessment of your response will occur one month after completing the therapy, with additional evaluations at four months.
Step 5
End of trial
The trial will conclude after the final assessments are completed. Your overall health and response to the treatment will be reviewed, and you will receive information about any further steps or treatments if necessary.

Who can join the trial?

15 criteria

Must have a confirmed diagnosis of neuroblastoma, a type of cancer that forms in certain types of nerve tissue.
Must have a test called immunohistochemical staining for somatostatin receptors (SSTR) done on the primary tumor tissue, if available.
Must provide written informed consent from the patient and/or parent(s) or legal guardian(s) before any trial-related procedures.
Must have relapsed or primary refractory high-risk neuroblastoma, which means the cancer has returned or not responded to treatment, and be classified as INSS stage 4 or INRGSS stage M.
Must be older than 18 months at the time of joining the study.
Must have a life expectancy of more than 3 months.
Must have a performance status score greater than 50%: Karnofsky for patients over 12 years old, and Lansky for patients 12 years old or younger. These scores measure the ability to perform daily activities.
Must have a two-week break from any prior treatment and recovery from any blood-related side effects and major surgery before starting the study treatment.
Must have certain diagnostic imaging tests done within two months before joining the study, including 68Ga-DOTATATE PET/CT, 123I-mIBG scintigraphy, and CT or MRI scans.
Must meet specific laboratory requirements within 7 days before starting the trial treatment, including:
- Hemoglobin levels, with a blood transfusion if less than 120 g/L.
- Absolute neutrophil count greater than 1.0 x 10⁹/L.
- Platelet count greater than 50 x 10⁹/L.
- Biochemistry tests for liver and kidney function within specified limits.
- Urinary catecholamine metabolites measured within 2 months before registration.
- Must have a minimum of 2 x 10⁶ CD34+ cells/kg of peripheral blood stem cells (PBSC) available, ideally 6 x 10⁶ CD34+ cells/kg, before joining the study.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer than neuroblastoma cannot participate.
Patients who have not experienced a return or worsening of their high-risk neuroblastoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments recently that might interfere with the study cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.

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Verified sites

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

Helse Bergen HF
Verified
Bergen, Norway
Hospital Sant Joan De Deu Barcelona
Verified
Esplugues De Llobregat, Spain
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Responsive
Vilnius, Lithuania

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Investigated drugs

177Lutetium-DOTATATE is a type of targeted therapy used in the treatment of certain cancers. It works by delivering radiation directly to cancer cells. This medication is designed to attach to specific receptors on the surface of the cancer cells, allowing the radioactive component to enter and destroy them from the inside. In this trial, it is being tested in children with a type of cancer called neuroblastoma, which has either come back after treatment or has not responded to previous treatments. The goal is to see how well this therapy works in shrinking the tumors and to determine the best dose to use for treatment.

What is already known about the treatment

177Lutetium-DOTATATE – This medication is administered through an injection into the bloodstream, specifically designed for children with a type of cancer called neuroblastoma that has either returned or not responded to previous treatments. Currently, it is being studied in clinical trials to determine the best dose and to see how well it works for these patients. The main use of 177Lutetium-DOTATATE is to treat high-risk neuroblastoma, a serious condition affecting nerve tissues. At the molecular level, it works by delivering targeted radiation to cancer cells, helping to destroy them while minimizing damage to healthy cells. It falls under the category of radiopharmaceuticals, which are drugs that contain radioactive substances used to treat certain types of cancer.

Investigated diseases

Neuroblastoma – Neuroblastoma is a type of cancer that forms in certain types of nerve tissue, most often in the adrenal glands, but it can also develop in the neck, chest, abdomen, or spine. It primarily affects children, especially those under the age of five. The disease begins when immature nerve cells, called neuroblasts, grow uncontrollably and form a tumor. As neuroblastoma progresses, it can spread to other parts of the body, including lymph nodes, bones, bone marrow, liver, and skin. The progression of the disease can vary, with some tumors growing slowly and others rapidly. Symptoms may include a lump in the abdomen, pain, or changes in bowel habits, depending on the tumor's location.