Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma

This study is looking at a new treatment for a type of aggressive brain cancer called glioblastoma. This new treatment uses light therapy during surgery after the main part of the tumour has been removed. It’s given in addition to standard chemotherapy (temozolomide). The main goal is to find out the safest amount of light to use. The study is split into two parts: first, finding the best dose, and then testing that dose further. This research is important because it could lead to better treatments for people with glioblastoma, by adding to the usual care they receive. It’s open to adults aged 18-75 who have been newly diagnosed.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Hemerion Therapeutics

Enrolment target

Start

20 Feb 2024

Estimated completion

01 Aug 2026

Primary Glioblastoma

What is this study about?

This study is focused on a serious type of brain cancer called glioblastoma. When someone has glioblastoma, doctors usually remove as much of the cancer as they can through surgery, and then give chemotherapy. This study is testing an extra treatment given during surgery, called "photodynamic therapy" (PDT).

Photodynamic therapy uses a special medicine and a special light. Before surgery, patients receive a medicine called 5-ALA HCl. This medicine makes cancer cells more sensitive to light. During the surgery, after the surgeon has removed as much of the main tumour as possible, a special light is shone on the area. The idea is that this light, combined with the medicine, can help to destroy any remaining cancer cells that the surgeon couldn't see or safely remove.

The main goal of this particular study is to find the safest amount of light to use for this treatment. It's a key first step to make sure the additional treatment is safe before it can be studied in more detail. The information gathered here will help design bigger studies in the future, with the hope of improving treatment for people with newly diagnosed glioblastoma.

Key takeaways

This study tests a new light treatment for glioblastoma during surgery.
It aims to find the safest dose of this light therapy to use.
This treatment is given in addition to standard chemotherapy.
It's for newly diagnosed adults aged 18-75.
The findings will help design future larger studies.

Who may be eligible?

To be able to take part in this study, you need to be an adult between 18 and 75 years old. You must have been newly diagnosed with a type of brain tumour called glioblastoma, and this diagnosis would have been made using MRI scans. Doctors need to believe that your tumour can be mostly removed by surgery and that you're well enough for the operation. You also need to be planning to have the usual chemotherapy treatment after your surgery.

There are also some reasons why you might not be able to join. For example, if you have other serious medical conditions like certain severe heart or kidney problems, or if your cancer affects too many areas of your brain. It's important that you don't have certain genetic conditions (like Lynch syndrome or Li-Fraumeni syndrome) or known allergies to some common ingredients like egg, soya, or peanut, as these might affect how you react to the study medicine. The doctors will check all these points carefully to make sure the study is right and safe 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 between 18 and 75 years old?
Have you recently been diagnosed with glioblastoma?
Are you able to have surgery to remove your tumour?
Are you planning to receive standard chemotherapy after surgery?
Do you have any serious heart, kidney, or liver conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the usual surgery for your glioblastoma, along with standard chemotherapy (temozolomide) after surgery. The study treatment involves taking a special medicine before surgery and then having a special light shone on the area where the tumour was during the operation. You will be assigned to receive one of two different light doses. Doctors will watch you very closely during and after the surgery to check how you are recovering and to make sure the treatment is safe.

Because this is a study to find the best dose, a group of independent medical experts will regularly check the safety information. They will decide if it's safe to move to the next dose level. After your surgery and initial recovery, you will continue with your standard chemotherapy treatment. You will also have regular follow-up appointments, similar to what you would have with standard care, for at least six months. This is to see how your recovery is going and to check for any tumour changes.

Potential risks and benefits

The potential benefit of taking part is that you might receive an additional treatment during surgery that could help destroy more cancer cells than with standard surgery alone. However, as this is a new treatment being studied, there's no guarantee it will improve your outcome, and there could be unknown risks. Potential risks include side effects from the study medicine or the light treatment, which will be carefully monitored. The study uses a dose-finding approach, meaning some participants will receive a lower dose of light initially. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

UPMC Hillman Cancer center
Verified postcode
Pittsburgh, United States
CHU De Lille, Hôpital Roger Salengro
Verified postcode
Lille, France

Common questions

What is glioblastoma?

Glioblastoma is a fast-growing and aggressive type of brain cancer that develops from star-shaped brain cells called astrocytes. It is a serious condition.

What does 'intraoperative' mean?

It means the treatment is given during surgery, while you are in the operating theatre.

What is photodynamic therapy (PDT)?

PDT is a treatment that uses a medicine activated by a special light to kill cancer cells. The medicine makes cancer cells more sensitive to the light.

What is the 'standard of care' for glioblastoma?

Standard of care usually means surgery to remove the tumour, followed by radiotherapy and chemotherapy (often temozolomide-based) to target any remaining cancer cells.

Will I know which dose of light I'm getting?

No, this study is 'open label,' meaning both you and your doctors will know you are receiving the study treatment, but the exact dose of light will be part of the study design to find the safest level.