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RecruitingPHASE2INTERVENTIONAL

Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma

This study is for people with glioblastoma, a very aggressive brain tumor. Current treatments often aren't enough, but simply increasing radiation can cause many side effects. This trial aims to use a higher dose of radiation alongside a special drug called bevacizumab. Bevacizumab is hoped to protect healthy areas of the brain, allowing a stronger attack on the tumor. Researchers want to see if this approach can improve how long patients live without causing more side effects. It’s a Phase 2 study, meaning it's still an early investigation into the effectiveness and safety of this new treatment combination.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
University Hospital Tuebingen
Enrolment target
146
Start
10 Apr 2024
Estimated completion
10 Jul 2028

What is this study about?

Glioblastoma is a very serious type of brain cancer. Even after treatment, it often grows back in the same area. Doctors believe that using a higher dose of radiation might be better at stopping the tumor. However, increasing the radiation dose can also harm healthy parts of the brain, leading to difficult side effects.

This study is trying a new approach. It suggests that by giving a drug called bevacizumab, doctors might be able to deliver a higher, more effective dose of radiation to the tumor without causing too many extra side effects. Think of bevacizumab as a helper that protects the healthy tissues while the radiation works harder on the cancer. The total radiation dose will be higher than usual, but given in slightly larger daily amounts over the treatment period.

The main aim of this study is to see if this new treatment combination can help people with glioblastoma live longer, and do so without making them sicker with more side effects than standard treatment. It's a Phase 2 study, which means researchers are still learning about how well it works and ensuring it's safe for people.

Key takeaways

  • Targets aggressive brain cancer (glioblastoma).
  • Combines higher radiation with a protective drug (bevacizumab).
  • Aims to improve survival without more side effects.
  • For individuals aged 18-70 with specific tumor characteristics.
  • Involves regular check-ups and scans.

Who may be eligible?

To join this study, you would need to have been recently diagnosed with a specific type of glioblastoma (called IDH wild-type, MGMT unmethylated). You should be between 18 and 70 years old, able to understand and agree to take part, and generally well enough to handle treatment. This includes having good blood counts and healthy kidney and liver function.

There are certain reasons why you might not be able to join. For example, if you've recently had major bleeding in your brain, if you're taking medicines that might interfere with bevacizumab, or if you have a weakened immune system. Also, severe heart problems, uncontrolled high blood pressure, or a previous allergy to bevacizumab would prevent you from participating. You also wouldn't be able to join if you've been treated with bevacizumab before.

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 you been diagnosed with glioblastoma that fits a specific type?
  2. Are you between 18 and 70 years old?
  3. Do you feel well enough for treatment, with good blood, kidney, and liver test results?
  4. Have you *not* had major bleeding in your brain after surgery?
  5. Are you *not* taking specific medications that might interfere with the study drug?
  6. Have you *not* had bevacizumab medicine for any reason before?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive two cycles of bevacizumab medication, followed by a specific type of radiation therapy given daily over several weeks. This radiation dose will be higher than standard treatment. Throughout the study, you'll have regular check-ups, which will likely include blood tests and MRI scans of your brain, to monitor your health and how the treatment is working. We don't have exact details on the total number of visits or the full duration here, but these specifics would be fully explained by the study team.

Potential risks and benefits

Potential benefits of joining this study could include a more effective treatment for your glioblastoma, which might lead to living longer. However, like all treatments, there are potential risks. Even with bevacizumab, a higher radiation dose could still cause more severe side effects than standard treatment. These risks would be fully explained by the study team. Remember, taking part in any study is completely voluntary, and you have the right to withdraw at any time without it affecting your usual medical care.

Locations (9)

  • Department of Radiation Oncology, University Hospital Augsburg
    Verified postcode
    Augsburg, Germany· Recruiting
  • Department of Radiation Oncology, University Hospital Köln
    Verified postcode
    Cologne, Germany· Recruiting
  • Department of Radiation Oncology, University Hospital Frankfurt
    Verified postcode
    Frankfurt, Germany· Recruiting
  • Department of Radiation Oncology, University Hospital Freiburg
    Verified postcode
    Freiburg im Breisgau, Germany· Recruiting
  • Department of Radiation Oncology, University Hospital Leipzig
    Verified postcode
    Leipzig, Germany· Recruiting
  • Department of Radiation Oncology, Medical Faculty Mannheim
    Verified postcode
    Mannheim, Germany· Recruiting
  • Department of Radiation Oncology, University Hospital, LMU Munich
    Verified postcode
    Munich, Germany· Recruiting
  • Department of Neurology, University Hospital Regensburg
    Verified postcode
    Regensburg, Germany· Recruiting
  • Department of Radiation Oncology
    Verified postcode
    Tübingen, Germany· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is a very fast-growing and aggressive type of brain tumor.

What is bevacizumab?

Bevacizumab is a medication that helps by limiting the growth of new blood vessels that tumors need to grow.

What does 'dose escalation' mean?

It means using a higher dose of radiation than what is typically given, to try and kill more cancer cells.

Why is this study being done?

Doctors want to find a way to give more effective radiation treatment for glioblastoma without increasing harmful side effects.

Is this a new treatment?

This study combines existing treatments (radiation and bevacizumab) in a new way, using a higher radiation dose alongside the drug.

How to find out more

Barbara Gehler, Dr. med.

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 "Protective VEGF Inhibition for Isotoxic Dose Escalation in G…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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