Study on the Safety of Lutetium (177Lu) Oxodotreotide, L-Lysine Hydrochloride, and L-Arginine Hydrochloride in Adolescents with Neuroendocrine Tumors and PPGLs

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What is this study about?

This clinical trial is focused on studying certain types of tumors, specifically gastroenteropancreatic neuroendocrine tumors (GEP-NETs), pheochromocytoma, and paragangliomas. These are rare types of tumors that can occur in the digestive system and other parts of the body. The study is testing a treatment called Lutathera, which is a solution given through an infusion into the veins. Lutathera contains a substance called lutetium (177Lu) oxodotreotide, which is designed to target and treat these tumors.

The purpose of the study is to evaluate how safe Lutathera is for use in adolescents and to understand how the body absorbs the radiation from this treatment. Another medication used in the study is called LysaKare, which contains L-lysine hydrochloride and L-arginine hydrochloride. These are amino acids that help protect the kidneys during the treatment. The study will involve monitoring the participants over a period of time to see how their bodies respond to the treatment and to check for any side effects.

Participants in the study will receive the treatment over a period of up to 36 months. During this time, doctors will closely monitor the participants’ health and the effects of the treatment. The study aims to gather information on the safety and effectiveness of Lutathera in treating these specific types of tumors in adolescents. This information will help in understanding how well the treatment works and its potential side effects.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of specific tumors and the expression of somatostatin receptors through imaging tests.

The assessment ensures that the patient is between 12 and 18 years old and meets the required health performance status.

2 treatment administration

The treatment involves the administration of Lutathera, a solution for infusion, given intravenously. This medication is used to target specific tumors.

Alongside Lutathera, LysaKare is also administered intravenously to protect the kidneys during treatment.

3 monitoring and evaluation

After the administration of Lutathera, the patient is monitored for any immediate adverse effects or laboratory abnormalities.

The primary focus is on evaluating the radiation doses absorbed by organs such as the kidneys and bone marrow.

4 short-term follow-up

For six months following the last dose of Lutathera, the patient undergoes regular check-ups to monitor for any adverse events or laboratory toxicities.

These follow-ups help in assessing the short-term safety and tolerability of the treatment.

5 long-term follow-up

The long-term follow-up extends up to five years after the final dose of Lutathera. During this period, the patient is periodically evaluated for any long-term adverse effects or laboratory abnormalities.

This stage aims to ensure the continued safety and effectiveness of the treatment over an extended period.

Who Can Join the Study?

The patient must have a type of tumor called GEP-NET or PPGL that has spread or cannot be removed by surgery. These tumors must be confirmed by a test called a histological test, which examines tissue under a microscope.
The patient must be between 12 and 17 years old at the time they join the study.
The patient must have somatostatin receptors on their tumors, confirmed by a special imaging test done within 3 months before joining the study. The test should show that the tumor absorbs a substance as much as or more than the normal liver does.
The patient must have a certain level of physical ability, measured by a Karnofsky score or Lansky Play-Performance Scale score of 50 or higher. These scores help determine how well the patient can perform daily activities.
The patient’s parent or guardian must be able to understand and agree to sign a consent form, which is a document that explains the study and what it involves. The adolescent will also need to agree to participate by signing a form, along with their parent or guardian, according to local rules.

Who Cannot Join the Study?

Patients who do not have somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors. These are specific types of tumors that affect the stomach, intestines, and pancreas and have certain receptors on their surface.
Patients who do not have pheochromocytoma or paragangliomas. These are rare types of tumors that usually develop in the adrenal glands or along nerve pathways in the body.
Patients who are not within the specified age range for the study.
Patients who are not able to safely receive the study treatment due to other health conditions.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend required visits.
Patients who have participated in another clinical trial recently.
Patients who have certain medical conditions that might interfere with the study treatment.
Patients who are taking medications that could affect the study results.
Patients who have allergies to the study medication or its ingredients.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Cifftq Lxpk Bvrgto	Lyon	France
Ntloxyjr Imfmregl Oadnzpqkv Icn Mmmjm Spinrbvfqcvpeiotcddlxnehvryw Iiyxxgep Boxdpxiz	Cracow	Poland
Hiafwmpj Vxqk diarmpul	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.09.2022
Poland	Not recruiting	08.09.2022
Spain	Not recruiting	08.09.2022

Trial locations

Investigated drugs:

Lutathera is a medication used in this clinical trial to treat certain types of tumors that have specific receptors called somatostatin receptors. These tumors include gastroenteropancreatic neuroendocrine tumors (GEP-NETs), pheochromocytomas, and paragangliomas. The trial aims to assess how safe Lutathera is for adolescent patients and how the body absorbs the radiation from this treatment.

Investigated diseases:

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) – These are a group of rare tumors that arise from neuroendocrine cells in the gastrointestinal tract and pancreas. They can produce hormones that cause various symptoms, depending on the location and type of tumor. GEP-NETs can grow slowly or rapidly, and their progression varies widely among individuals. They may remain localized or spread to other parts of the body over time.

Pheochromocytoma – This is a rare tumor that develops in the adrenal glands, which are located above the kidneys. It often causes the glands to produce excess hormones, leading to symptoms like high blood pressure, headaches, and sweating. The tumor can grow slowly and may remain confined to the adrenal glands or spread to other areas.

Paragangliomas – These are rare tumors that originate from nerve tissue outside the adrenal glands. They can occur in various parts of the body and may produce hormones that lead to symptoms similar to pheochromocytomas. Paragangliomas can grow at different rates and may remain localized or spread to other regions.

Trial ID:

2023-507444-37-00

Protocol code:

CAAA601A32201

NCT ID:

NCT04711135

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of Lutetium (177Lu) Oxodotreotide, L-Lysine Hydrochloride, and L-Arginine Hydrochloride in Adolescents with Neuroendocrine Tumors and PPGLs

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?