All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

This study is testing a new way to treat a serious type of brain cancer called glioblastoma. It combines the usual treatments, which are radiotherapy (using radiation to kill cancer cells) and a medicine called Temozolomide (TMZ), with tiny new particles called AGuIX nanoparticles. These nanoparticles are designed to make the radiotherapy work better. The first part of the study (Phase 1) is about finding the right dose of AGuIX to use safely alongside the standard treatments. The second part (Phase 2) will then check how well this combined treatment works. We want to see if it helps patients live longer without their cancer growing for at least six months. This research aims to improve treatments for people with newly diagnosed glioblastoma.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Centre Jean Perrin
Enrolment target
66
Start
07 Mar 2022
Estimated completion
01 Mar 2027

What is this study about?

This study is investigating a new treatment approach for newly diagnosed glioblastoma, which is a type of brain cancer. Currently, the standard treatment involves radiotherapy (focused radiation to target cancer cells) and a medicine called Temozolomide (TMZ). This study adds something new to this standard approach: tiny particles called AGuIX nanoparticles.

AGuIX nanoparticles are designed to make the radiotherapy more effective by helping the radiation target the cancer cells better. The idea is that these nanoparticles might improve how well the treatment works without significantly increasing side effects. By making the existing treatments stronger, researchers hope to give patients a better chance against their cancer.

The study has two main steps. The first step (Phase 1) is about safety – giving the AGuIX nanoparticles in a carefully controlled way at different doses (50 mg/kg, 75 mg/kg, and 100 mg/kg) to find the highest dose that is safe to use with radiotherapy and TMZ. Once the best dose is found, the second step (Phase 2) will focus on how well this new combined treatment works, specifically by looking at how many patients are living without their cancer growing after six months.

Key takeaways

  • This study is for newly diagnosed glioblastoma.
  • It combines standard treatment with new 'nanoparticles' to boost radiotherapy.
  • The first stage is to find a safe dose of the nanoparticles.
  • The next stage checks if the combined treatment helps patients live longer without cancer growth.
  • Participants will receive nanoparticles via a drip, plus radiotherapy and Temozolomide.
  • Regular checks and monitoring will be part of the study.

Who may be eligible?

To join this study, you would need to have been recently diagnosed with glioblastoma and meet certain health requirements. This means your doctors would have confirmed your diagnosis, and if you had surgery, it was either a biopsy or a partial removal of the tumour. You should generally be in good health, able to look after yourself, and be between 18 and 75 years old.

There are also specific health checks that need to be met, such as having healthy blood cell counts (like enough platelets and white blood cells) and your kidneys and liver working well. If you're taking steroid medication, the dose needs to have been steady or reducing for at least two weeks before you start. You also need to be able to take medicines by mouth.

However, you wouldn't be able to join if you've already had brain radiotherapy or certain chemotherapy treatments for your cancer. Other reasons you might not be able to join include having certain gut problems, severe diarrhoea, or if you're currently in another medical trial. Also, if you've had another type of cancer in the last five years (except for some very common skin cancers), you might not be eligible. Women who could become pregnant would need to have a negative pregnancy test and agree to use effective birth control during and after the trial.

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.

  1. Have I been recently diagnosed with glioblastoma?
  2. Am I generally in good health and able to look after myself?
  3. Am I between 18 and 75 years old?
  4. Have I not had brain radiotherapy or certain chemotherapy before?
  5. Do I have healthy blood counts and good kidney/liver function?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the AGuIX nanoparticles through a drip into your arm, along with your regular radiotherapy and Temozolomide medication. The AGuIX will be given at a specific dose determined in the study.

You will have several visits to the hospital for treatments, blood tests, and check-ups to see how you are responding and to monitor for any side effects. These assessments will involve speaking with the study doctor and nurses, and possibly having scans or other tests. The exact number and frequency of visits will be explained to you, but typically, clinical trials involve regular monitoring during the treatment period and then follow-up appointments afterwards. The total duration someone is in the study will vary, but it will involve a treatment phase and then a period where you are monitored after treatment ends.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, as you would be among the first to receive this new treatment combination which might be more effective than standard care. However, because it's a new treatment, there are also potential risks. The AGuIX nanoparticles might cause side effects that we don't fully know about yet, or they could interact with your other treatments. The medical team will carefully monitor you for any problems. You will have full details about known risks and benefits before deciding, and it's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

  • CHU de Brest
    Verified postcode
    Brest, France
  • Centre Jean Perrin
    Verified postcode
    Clermont-Ferrand, France
  • CHU de Grenoble
    Verified postcode
    Grenoble, France
  • Centre Léon Berard
    Verified postcode
    Lyon, France
  • Hospices Civils de Lyon
    Verified postcode
    Lyon, France
  • Hôpital La Pitié Salpetrière
    Verified postcode
    Paris, France
  • Institut de Cancérologie de l'Ouest
    Verified postcode
    Saint-Herblain, France
  • Institut de Cancérologie Strasbourg Europe
    Verified postcode
    Strasbourg, France
  • Institut Gustave Roussy
    Verified postcode
    Villejuif, France

Common questions

What is glioblastoma?

Glioblastoma is a very serious type of brain cancer that grows quickly. Finding new and better treatments for it is very important.

What are AGuIX nanoparticles?

AGuIX nanoparticles are tiny new particles being tested to see if they can help make radiotherapy work better against cancer cells.

What is Temozolomide (TMZ)?

TMZ is a chemotherapy medicine that is commonly used alongside radiotherapy to treat glioblastoma.

What does 'Phase 1/2' mean for a study?

Phase 1 is about checking if a new treatment is safe and finding the right dose. Phase 2 then looks at how well that treatment works.

How will I receive the AGuIX nanoparticles?

The AGuIX nanoparticles will be given to you through a drip in your arm.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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