Active not recruitingPHASE1INTERVENTIONAL

"Re-Stimulated" TILs and IL-2 Therapy for Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This early-stage study is for women diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer that has recurred and is resistant to platinum-based chemotherapy. The research explores a new treatment strategy using your body's own immune cells, called 'tumor-infiltrating lymphocytes' (TILs). These TILs are taken from your tumor, grown in a lab, and then given back to you. The idea is to make these natural cancer-fighting cells stronger and more effective against the cancer. You would also receive other medications like cyclophosphamide and interleukin-2 (IL-2) as part of the treatment plan. This is a Phase 1 study, meaning the main goal is to check the safety of this new combination and to see if the treatment works as expected.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Jan 2015

Estimated completion

01 Jun 2026

Recurrent Platinum-resistant High Grade Serous Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

What is this study about?

This study is looking at a new way to treat certain advanced cancers affecting the ovaries, fallopian tubes, or the lining of the abdomen (peritoneum). Specifically, it's for women whose cancer has returned after initial treatment and is no longer responding to chemotherapy medicines that contain platinum.

The main treatment in this study involves using a type of your own white blood cells called 'tumor-infiltrating lymphocytes' – or TILs for short. These TILs are special because they naturally recognise and try to attack cancer cells. In this study, doctors would take a small piece of your tumour. From this sample, they would find and grow your TILs in a lab, also giving them a boost with other substances, including something called 'dendritic cells' and an antibody called OKT3. The goal is to make these TILs stronger and more numerous so they can fight the cancer better.

Once ready, these boosted TILs are given back to you through a drip. Before the TILs, you’ll also receive a medicine called cyclophosphamide. After the TILs, you'll get another medicine called interleukin-2 (IL-2). Doctors hope that this combination of treatments will help your immune system recognise and destroy the cancer cells more effectively. Because this is a Phase 1 study, the main aim is to understand if this new combination of treatments is safe, what the right dose might be, and to see early signs of how well it works.

Key takeaways

This study is for advanced ovarian, fallopian tube, or peritoneal cancer no longer responding to platinum chemotherapy.
It uses your own immune cells (TILs) taken from your tumour, grown, and given back to you.
Other medications (cyclophosphamide, IL-2) are part of the treatment.
It's a Phase 1 study, focusing on safety and early signs of effectiveness.
You might need a small operation to provide a tumour sample.
Participation involves regular hospital visits, tests, and monitoring.

Who may be eligible?

To join this study, you must be at least 18 years old and have ovarian, fallopian tube, or primary peritoneal cancer that has returned and is resistant to platinum-based chemotherapy. Doctors will need to confirm your type of cancer. You also need to have areas of active cancer that can be measured.

An important part of this study is taking a small piece of your tumour. This piece needs to be big enough (at least 1 cubic centimetre) for the researchers to collect the special immune cells called TILs. If you've had a tumour sample taken for a similar study before, that might count. Your overall health and fitness for surgery to get this tumour sample will also be checked.

Overall, you should be well enough to take part, with a good chance of living more than five months. You must also be willing to be tested for certain infections and understand what the study involves before you agree to take part.

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?
Do you have ovarian, fallopian tube, or primary peritoneal cancer that has come back and is resistant to platinum-based chemotherapy?
Do you have areas of cancer that doctors can measure?
Are you generally well enough to participate in a study?
Are you willing to have a small piece of your tumour removed if needed for the study?
Are you willing to be tested for certain infections?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it starts by checking if your tumour is suitable for harvesting the special immune cells (TILs). This might involve a small operation to remove a piece of your tumour. Once this is done, the cells will be grown and prepared in a lab, which takes some time.

When treatment is ready, you’ll first receive a medication called cyclophosphamide, given by drip. Shortly after, you’ll receive your own specially prepared TILs, also through a drip. Following this, you will have regular doses of another medication called interleukin-2 (IL-2). Over time, you will have regular blood tests, scans, and doctor appointments to monitor your health, how you’re responding to the treatment, and any side effects you might experience. The total duration of your participation will depend on how you respond to treatment and will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new treatment that might help fight your cancer, especially if standard treatments are no longer working. However, this is an early-stage study, so the full benefits are not yet known. Like all medical treatments, there are potential risks and side effects from the medications and procedures involved, which the study team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What are TILs?

TILs, or tumour-infiltrating lymphocytes, are a type of white blood cell that naturally exists in your body and can recognise and fight cancer cells within a tumour.

What does 'platinum-resistant' mean?

It means your cancer has stopped responding to chemotherapy medicines that contain platinum, which are often used as standard treatments.

Is this a new type of treatment?

Yes, this study is testing a new combination of treatments, including using your own immune cells, which is an experimental approach.

Will I need surgery to join the study?

You might need a small operation to remove a piece of your tumour so the researchers can collect the special immune cells needed for the treatment.

What is a Phase 1 study?

Phase 1 studies are the first step in testing a new treatment in people. The main goals are to check if it's safe, find the right dose, and see if there are any early signs that it might work.