AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

The ALPINE trial: a phase 1-2 study of intra-arterial [177Lu]Lu-PSMA-I&T for progressive or recurrent intracranial adult type diffuse glioma

The ALPINE study is an early-stage clinical trial for adults with certain types of brain tumours, specifically diffuse glioma (such as astrocytoma, oligodendroglioma, or glioblastoma) that are growing or have come back. The study is testing a new treatment called [177Lu]Lu-PSMA-I&T. This special liquid medication is given directly into the blood vessels of the brain through a procedure called intra-arterial delivery. It’s a first look at this treatment in humans, so the main goals are to check if it’s safe, to understand any side effects, and to see if it shows promise in treating these brain tumours. As an early-stage study, it's about gathering initial information to guide future research.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

17 Jul 2023

Glioma (diffuse astrocytoma oligodendroglioma or glioblastoma)

What is this study about?

The ALPINE study is focused on developing new treatments for adult brain tumours, specifically a group known as diffuse gliomas. These include conditions like astrocytoma, oligodendroglioma, and glioblastoma, which are types of cancer that start in the brain. When these tumours grow despite existing treatments or come back after treatment, doctors are always looking for new options. This study aims to explore one such new option.

The experimental treatment being tested is called [177Lu]Lu-PSMA-I&T. This isn't like a standard chemotherapy pill or radiation from outside the body. Instead, it's a radioactive liquid medication that is delivered very precisely. A tiny tube (catheter) is guided directly into the blood vessels that supply the brain tumour. This method, called intra-arterial delivery, helps to deliver the medication right where it's needed, potentially reducing effects on other healthy parts of the body.

This is an early-stage study, known as Phase I and Phase II. This means it's one of the first times this treatment is being given to people. The main goals are to find out if the treatment is safe, what the right dose might be, and to understand any potential side effects. Researchers will also be looking for early signs of how effective it might be against the brain tumours. The information gathered from this study will be crucial for deciding whether to move forward with larger studies.

Key takeaways

This study is testing a new, targeted treatment for adult brain tumours (diffuse gliomas).
The treatment involves a special liquid medication delivered directly into brain arteries.
It's an early-stage study focused on safety, side effects, and early signs of effectiveness.
It's for adults whose brain tumours are growing or have come back.
Participation involves medical tests, the treatment procedure, and regular follow-up appointments.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. Both men and women can take part. The study is for people who have specific types of brain tumours called diffuse gliomas. This includes diffuse astrocytoma, oligodendroglioma, or glioblastoma.

Crucially, your tumour must be either growing larger or have come back after previous treatments. The research team will need to review your medical records, including details about your brain tumour and any treatments you've had, to make sure this study is right for you. There will be other specific health requirements that the study doctors will discuss in detail.

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 18 years old or older?
Have you been diagnosed with a diffuse glioma (e.g., astrocytoma, oligodendroglioma, or glioblastoma)?
Is your brain tumour currently growing or has it come back after previous treatment?
Are you able to attend appointments at the study hospital?
Are you able to understand and be willing to follow the study procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a number of tests and scans to check if the study is right for you. If you qualify, you would receive the study medication, [177Lu]Lu-PSMA-I&T, which involves a procedure to deliver it directly to your brain's blood vessels. This procedure would require a hospital stay.

After receiving the treatment, you would have regular follow-up appointments, including scans (like MRI) and blood tests, to monitor your health, check for any side effects, and see how the treatment is affecting your tumour. The exact number of visits and the total duration in the study would be explained by the study team, but generally, early-stage trials involve close monitoring over several months.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't widely available, which might potentially help your condition. However, new treatments also come with unknown risks and potential side effects that researchers are still learning about. You would have a team of doctors and nurses closely monitoring your health throughout the study. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Netherlands
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Unverified
Norway

Common questions

What exactly is a diffuse glioma?

Diffuse glioma is a general term for certain types of brain tumours that tend to grow in an uncontrolled way among normal brain cells, rather than as a clearly defined lump. Examples include astrocytoma, oligodendroglioma, and glioblastoma.

What does 'intra-arterial' mean?

It means the medication is put directly into an artery (a blood vessel that carries blood from the heart) using a thin tube. In this study, it's delivered to the arteries supplying the brain tumour for very targeted treatment.

What is [177Lu]Lu-PSMA-I&T?

It's a special type of liquid medication that carries a mild radioactive substance (Lutetium-177) that targets specific features on cancer cells, aiming to damage them while sparing healthy tissue. It's still in the early stages of being tested.

Will this drug cure my cancer?

It's too early to say if this treatment can cure cancer. This is an early-stage study primarily focused on safety and understanding how the treatment works. The hope is that it could eventually offer a new way to treat these tumours.

What do 'Phase I' and 'Phase II' mean?

These are early steps in testing new treatments. Phase I usually involves a small group of people to check safety and find the right dose. Phase II looks at safety in a slightly larger group and starts to see if the treatment has any effect on the illness.