Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTA0-Tyr3-Octreotate in Children with Refractory or Recurrent Neuroblastoma expressing somatostatin receptors

This study is for children who have neuroblastoma, a type of cancer, that has either come back after treatment or isn't responding to their current treatments. Doctors are testing a new medicine called Lutathera. This treatment uses a special type of radiation that targets cancer cells. The most important goal of this early-stage study is to find the safest dose of Lutathera for children. They will carefully watch children for six weeks after they receive the first dose to see how their bodies react and to make sure the dose is well-tolerated. They will also be looking at how effective the treatment is and closely monitoring any side effects to ensure safety.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Oncopole Claudius Regaud

Enrolment target

Start

02 Aug 2024

Recurrent or refractory neuroblastoma.

What is this study about?

This study is an early-stage clinical trial looking into a potential new treatment for children with neuroblastoma, a type of cancer that starts in nerve cells. Specifically, it's for children whose neuroblastoma has either returned after previous treatments or hasn't responded to those treatments.

The treatment being tested is called Lutathera (you may hear it called PRRT), which is given as a liquid into a vein. This medicine works by delivering a small amount of radiation directly to the cancer cells, aiming to kill them more effectively. At this stage, doctors are mainly focused on finding the safest amount of Lutathera to give. They want to make sure the dose they use is effective against the cancer without causing too many side effects.

Over the course of the study, doctors will pay very close attention to how each child's body responds to the treatment, particularly in the first six weeks after the first dose. They will be looking for any side effects and carefully monitoring the treatment's effects on different organs, especially the kidneys. They will also be checking to see if the treatment helps to shrink or control the cancer.

Key takeaways

This study is testing a new treatment called Lutathera for children with neuroblastoma.
It's for children whose cancer has come back or not responded to other treatments.
The main goal is to find the safest dose of the new medicine.
Children will be closely monitored for any side effects and how the cancer responds.
It's an early-stage study, and doctors are learning how well this new treatment works.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for children with neuroblastoma. To be considered, their cancer must have either come back after previous treatments or not responded well to treatments they've already had. The study does not have any specific age limits, meaning it's open to children of various ages with this condition.

Both boys and girls can take part in this study, as long as they meet the other specific health requirements that the doctors will check. These exact requirements will be explained by the study team to make sure it's the right choice for each child.

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.

Is my child diagnosed with neuroblastoma?
Has my child's neuroblastoma come back after treatment?
Or, has my child's neuroblastoma not responded to previous treatments?
Is my child currently a patient at a hospital or clinic that is part of this study?
Am I willing to have my child attend regular check-ups and follow study procedures?

Answer every question to see your result.

What does participation involve?

If a child joins this study, they will receive the study medicine, Lutathera, through a drip into their vein. Another medicine, LysaKare, will also be given this way. Doctors will monitor the child very closely, especially in the first six weeks after each dose of Lutathera, to see how their body reacts and to check for any side effects. There will be regular check-ups, blood tests, and scans to see how the cancer is responding and to monitor the child's overall health. These visits will continue for a period, which the study team will explain in detail. The total time a child spends in the study will depend on their individual response to the treatment.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a new treatment for neuroblastoma, which might help when standard treatments haven't worked or the cancer has returned. However, as with any new treatment, there are potential risks, including side effects from the medication. The study team will carefully monitor for these and will explain them fully. It's important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (1)

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

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Unverified
France

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that starts in very young nerve cells, usually in babies and young children.

What is Lutathera?

Lutathera is the name of the new treatment being tested. It's a special type of medicine that delivers targeted radiation to cancer cells.

What does 'refractory or recurrent' mean?

It means the cancer has either not responded to previous treatments (refractory) or has come back after treatment (recurrent).

What does Phase I mean?

Phase I is the earliest stage of a study where doctors give a new treatment to a small group of people for the first time. The main goal is to find a safe dose and see if there are any serious side effects.

Will my child get better if they join?

Because this is an early-stage study, we cannot guarantee your child will get better. The study aims to find a safe dose and see how well it works. The doctors will monitor your child's health and cancer response very carefully.