Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of the feasibility of PD L 506 for stereotactic interstitial photodynamic therapy (iPDT) in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma

This study aims to investigate a new treatment approach for adults who have recently been diagnosed with a specific type of brain cancer called glioblastoma. The treatment, called stereotactic interstitial photodynamic therapy (iPDT), involves a light-activated medication. The main goal is to find out how safe and practical this new treatment is. Researchers will be closely watching for any side effects that might happen within two weeks after the treatment. This is a Phase II study, which means it's an early stage of testing to explore if the treatment shows promise before it can be offered more widely. The study is open to both men and women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Photonamic GmbH & Co. KG

Enrolment target

Start

05 Jul 2024

Glioblastoma

What is this study about?

This clinical trial is designed to investigate a new type of treatment for a serious brain cancer called glioblastoma. Glioblastoma is a fast-growing brain tumour. The treatment being studied here is called 'stereotactic interstitial photodynamic therapy' (iPDT). In simpler terms, this means using a special light directly within the brain tumour after giving a medication called Gliolan. This medication makes cancer cells more sensitive to light, and when the light is applied, it helps to destroy those cells.

The main purpose of this study is to see if this new treatment method is safe and practical for patients. This is really important because it helps doctors understand if the treatment can be given without causing too many serious side effects. They will be very carefully monitoring patients for any side effects, especially in the first two weeks after the treatment.

This is a 'Phase II' study. Think of clinical trials in phases – Phase I studies check if a treatment is safe, Phase II studies explore if it works and is practical, and Phase III studies compare it to existing treatments. So, this study is a step towards understanding if iPDT could one day become a useful treatment option for people with glioblastoma.

Key takeaways

This study is testing a new light-based treatment for glioblastoma.
It's for adults newly diagnosed with a specific type of glioblastoma.
The main aim is to check how safe and practical the treatment is (Phase II study).
Patients will be closely monitored for side effects, especially in the first two weeks.
You'll take a special drink (Gliolan) before the light treatment.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning older adults can also participate if they meet other health requirements.

This study is for people who have been recently diagnosed with a specific type of brain tumour called 'supratentorial IDH wild-type glioblastoma'. This is a very particular diagnosis, and your doctor will be able to confirm if your cancer matches this description.

Both men and women are welcome to take part in this research. Your medical team will review your full health history to make sure this study is suitable for you.

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 recently been diagnosed with glioblastoma?
Has your doctor confirmed it's 'supratentorial IDH wild-type glioblastoma'?
Are you able to attend regular follow-up appointments?
Are you male or female?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first have a number of tests and checks to make sure the treatment is right for you. Before the treatment, you will be given a medication called Gliolan to drink, which helps make the cancer cells sensitive to light. The main part of the treatment will involve a procedure where special light is delivered directly to the tumour. After the treatment, you will be closely monitored by the study team. They will be looking for any side effects and how you are recovering. You will have regular check-ups and appointments for at least two weeks after the treatment, and potentially for a longer period, to make sure you are doing well and to assess the effects of the treatment. The total duration of your participation will depend on the monitoring schedule set by the researchers, but the primary focus for side effects is within the first two weeks.

Potential risks and benefits

Participating in this study might offer potential benefits, as you would be trying a new treatment that isn't widely available yet, which could potentially improve your outlook. However, as with any new treatment, there are potential risks. The researchers will be closely monitoring for any side effects following the treatment, especially in the first two weeks. Your doctors will explain all known and possible risks in detail before you decide to take part. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Germany

Common questions

What is glioblastoma?

Glioblastoma is a serious and fast-growing type of brain tumour.

What is iPDT?

iPDT stands for 'stereotactic interstitial photodynamic therapy' – it's a treatment that uses light to destroy cancer cells after you've taken a special drug.

What does 'Phase II' mean?

Phase II means this is an early study to see if the new treatment is safe and practical, before it's compared to existing treatments.

Will I have to take any medication?

Yes, you will likely take a medication called Gliolan (as a drink) before the light treatment.

How long will I be monitored after treatment?

You will be closely monitored for at least two weeks after the treatment to check for any side effects.