All studies
RecruitingPHASE3INTERVENTIONAL

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

This study is for adults with a type of brain tumour called glioblastoma that has unfortunately returned. Doctors want to see if combining a new ultrasound device, SonoCloud-9, with an anti-cancer drug called carboplatin is more effective than usual treatments like Lomustine or Temozolomide. The SonoCloud-9 device helps open up the brain's protective barrier, allowing more of the carboplatin drug to reach the tumour. Researchers hope this combination will improve how well the treatment works for patients. The study aims to gather more information to help future patients with this challenging condition.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
CarThera
Enrolment target
560
Start
29 Jan 2024
Estimated completion
30 Jun 2028

What is this study about?

When we talk about brain tumours, one of the biggest challenges for doctors is getting medicines into the brain. The brain has a natural protection called the 'blood-brain barrier' which is like a very strong filter. It stops harmful substances from getting into your brain, but it also stops many helpful medicines, like those used to treat cancer, from reaching the tumour.

This study is testing a new device called SonoCloud-9. It uses special sound waves (ultrasound) to gently and temporarily open up this blood-brain barrier specifically around the tumour. This means that a chemotherapy drug called carboplatin, which is known to fight cancer cells, might be able to get into the tumour area more easily and in higher amounts. Carboplatin has been used to treat various cancers, and laboratory studies show it can affect glioblastoma cells, but it usually struggles to cross the blood-brain barrier on its own.

The main goal of this research is to see if using SonoCloud-9 with carboplatin works better at treating glioblastoma that has returned, compared to the standard chemotherapy treatments currently used, which are Lomustine or Temozolomide. By helping more of the drug reach the tumour, researchers hope this new approach could lead to more effective treatment for patients.

Key takeaways

  • Tests a new approach for recurrent glioblastoma.
  • Uses SonoCloud-9 ultrasound device to open the blood-brain barrier.
  • Aims to get more carboplatin chemotherapy drug to the tumour.
  • Compares this new combination to standard chemotherapy.
  • For adults aged 18 and over.

Who may be eligible?

This study is looking for adult patients (18 years or older) who have been diagnosed with a specific type of brain tumour called glioblastoma, which has unfortunately grown back after previous treatment. You would have already received standard treatments like surgery, radiotherapy, and some chemotherapy or other anti-cancer therapies.

Doctors would need to see clear signs that the tumour has grown back, and it needs to be of a certain size shown on a brain scan (MRI). You would also need to be fit enough for surgery, and your body's essential functions, like blood counts and liver, should be working reasonably well. There's also a waiting period after your last cancer treatment before you can join to make sure your body has recovered enough.

Your doctors will carefully check all your medical information and scan results to see if this study is suitable for you. They will explain everything in detail so you can make an informed decision.

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. Are you 18 years old or older?
  2. Have you been diagnosed with glioblastoma that has returned after initial treatment?
  3. Have you had previous surgery, radiotherapy, and other cancer treatments?
  4. Are you generally well enough for surgery and active medical treatments?
  5. Has it been at least 12 weeks since you finished your last course of radiotherapy?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular hospital visits for assessments, scans (like MRI), and receiving the study treatments. If you are in the group receiving SonoCloud-9 and Carboplatin, the SonoCloud-9 device would be placed at the time of your tumour surgery, and then activated during treatment sessions to open the blood-brain barrier. Both SonoCloud-9 and carboplatin would be given according to a specific schedule over several months. If you are in the control group, you would receive either Lomustine or Temozolomide according to standard treatment schedules.

There will be follow-up appointments to monitor your health and the tumour's response to treatment. The total length of your participation would depend on how your treatment progresses and your doctor's recommendations, but typically involves several months of active treatment and follow-up over a longer period.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment approach that is not yet widely available, and you would be closely monitored by medical professionals. However, there are also potential risks involved, including side effects from the treatments (SonoCloud-9, carboplatin, Lomustine, or Temozolomide), which your doctor will explain in detail. The SonoCloud-9 is an investigational device, meaning its full effects are still being studied. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (48)

  • Mayo Clinic Arizona
    Verified postcode
    Phoenix, United States· Active not recruiting
  • University of California, San Francisco
    Verified postcode
    San Francisco, United States· Active not recruiting
  • UCHealth
    Verified postcode
    Aurora, United States· Active not recruiting
  • Mayo Clinic of Jacksonville Florida
    Verified postcode
    Jacksonville, United States· Active not recruiting
  • Miami Cancer Institute
    Verified postcode
    Miami, United States· Active not recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Active not recruiting
  • Winship Cancer Institute at Emory University
    Verified postcode
    Atlanta, United States· Active not recruiting
  • Northwestern University
    Verified postcode
    Chicago, United States· Active not recruiting
  • Indiana University Health
    Verified postcode
    Indianapolis, United States· Active not recruiting
  • John Hopkins University
    Verified postcode
    Baltimore, United States· Active not recruiting
  • Mayo Clinic Rochester
    Verified postcode
    Rochester, United States· Active not recruiting
  • Weill Cornell Medicine
    Verified postcode
    New York, United States· Active not recruiting

Common questions

What is Glioblastoma?

Glioblastoma is an aggressive type of brain cancer that starts in the brain or spinal cord.

What is the 'blood-brain barrier'?

It's a protective shield that stops many substances, including some medicines, from easily getting into your brain.

What does SonoCloud-9 do?

It's a device that uses sound waves to temporarily open up the blood-brain barrier around the tumour, allowing medicines to enter more easily.

What is Carboplatin?

Carboplatin is a chemotherapy drug used to treat various cancers.

Why is this study being done?

Researchers want to see if combining SonoCloud-9 with carboplatin works better for glioblastoma that has come back, compared to standard treatments.

How to find out more

Carole Desseaux

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

Interested in taking part?

Register your interest

Share your details and the research team for "Sonocloud-9 in Association With Carboplatin Versus Standard-…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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