Active not recruitingPHASE2INTERVENTIONAL

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

This study is for young people aged 12 to 17 who have certain types of cancer called Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) or Pheochromocytoma and Paraganglioma (PPGLs). It's testing a treatment called Lutathera. The main goal is to understand how safe Lutathera is for teenagers and how it spreads in the body. Patients will receive four doses of Lutathera over several months, along with other medicines to protect their kidneys and prevent sickness. Researchers will closely watch patients during and after treatment, including for a long period of 10 years, to make sure it's safe and effective. This study is important for finding new ways to help young people with these cancers.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Advanced Accelerator Applications

Enrolment target

Start

31 Aug 2022

Estimated completion

06 Feb 2034

Gastroenteropancreatic Neuroendocrine Tumors Pheochromocytoma Paraganglioma

Results

Results from this study

Posted November 2024

Results have been published for this study.

Primary outcome

Absorbed Radiation Doses in Target Organ

Absorbed radiation doses in target organ (e.g. kidney and bone marrow) was evaluated when all Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) and Pheochromocytoma and paraganglioma (PPGLs) as a pooled cohort patients had completed the 1st treatment of Lutathera and completed the dosimetry assessment.

Full results on the registry

What is this study about?

This study is looking into a treatment called Lutathera for teenagers aged 12 to 17. The types of cancer it's focusing on are Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) and Pheochromocytoma and Paraganglioma (PPGLs). These are rare cancers that can affect different parts of the body. Lutathera is a special type of medicine that uses a small amount of radiation to target and treat cancer cells.

The main purpose of this study is to find out how safe Lutathera is for young people and to understand how it moves through their bodies. This information, called 'dosimetry', helps doctors figure out the right amount of medicine to give. The study aims to make sure that the treatment is as effective as possible while keeping side effects to a minimum. By gathering this important information, doctors can learn more about how to best use Lutathera to help teenagers with these specific cancers.

Researchers will carefully monitor each patient thought the study to ensure their safety. This research is a significant step towards potentially improving treatment options and the quality of life for young people dealing with GEP-NETs and PPGLs.

Key takeaways

This study is testing Lutathera for teenagers with specific rare cancers.
It aims to understand safety and how the medicine works in the body.
Participants will receive four treatments over several months.
Kidney protection and anti-sickness medication are given with treatment.
There's a long follow-up period to check on long-term safety and results.
Parents/guardians and the teenager must agree for participation.

Who may be eligible?

To join this study, people generally need to be between 12 and 17 years old and have been diagnosed with either a GEP-NET or PPGL cancer that has spread or cannot be removed by surgery. Doctors will check that your specific type of cancer has certain features that show it might respond to the treatment being tested.

There are also some important health checks. Your blood test results, for example, need to be within a healthy range. You won't be able to join if you are pregnant, breastfeeding, or planning to become pregnant, or if you have certain other serious health problems that might make the treatment unsafe. Both male and female patients need to agree to use effective contraception during and for some time after the study.

Finally, because you are under 18, your parent or legal guardian will need to agree and give their permission for you to take part. You will also have a say and agree to participate yourself.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 12 and 17 years old?
Do you have a GEP-NET or PPGL cancer that has spread or cannot be operated on?
Have your doctor confirmed your cancer has specific receptors (targets) that Lutathera can attach to?
Are your blood test results (like blood counts and kidney function) within healthy ranges?
Are you able to use effective contraception if needed (or not pregnant/breastfeeding)?
Are you and your parents/guardians willing to agree to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a screening period that lasts up to two weeks. This is when doctors will do tests to make sure the study is right for you. If you are eligible, you will receive four treatments of Lutathera. Each treatment will be given about every eight weeks. During each treatment, you'll also get some amino acids (special proteins) through a drip to help protect your kidneys, and medicine to prevent you from feeling sick.

After your first Lutathera dose, doctors will do special scans and tests to see exactly how the medicine moves in your body. This helps them plan any future doses. Your health will be carefully checked before each treatment.

After all four treatments, you will have a long follow-up period stretching over 10 years. This is to make sure you are doing well and to see the long-term effects of the treatment. This full study journey, from screening to the end of follow-up, could last just over 10 years.

Potential risks and benefits

Taking part in this study could offer you the chance to receive a new treatment for your specific type of cancer that is not yet widely available for teenagers. Doctors will learn valuable information that could help other young people in the future. However, like all medicines, Lutathera has potential side effects. These can include feeling sick, changes in blood counts, and effects on your kidneys or other organs. You will be closely monitored to manage any side effects. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Kentucky
Verified postcode
Lexington, United States
Cincinnati Children's Hospital
Verified postcode
Cincinnati, United States
Children's Hospital of Philadelphia
Verified postcode
Philadelphia, United States
Centre Léon Berard
Verified postcode
Lyon, France
Maria Sklodowska-Curie National Research Institute of Oncology
Verified postcode
Gliwice, Poland
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain
University College Hospital of London
Verified postcode
London, United Kingdom

Common questions

What is Lutathera?

Lutathera is a special medicine that uses a small amount of radiation to target and treat specific types of cancer cells in the body.

What kinds of cancer is this study for?

This study is for teenagers with Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) or Pheochromocytoma and Paraganglioma (PPGLs).

How long does the treatment last?

You will receive four treatments of Lutathera, with each one given roughly every eight weeks. The total follow-up period after treatment is 10 years.

Will I get sick during treatment?

You'll receive medicine to help prevent feeling sick and to protect your kidneys during the Lutathera infusions.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect your ongoing medical care.