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Study of Tumor-Infiltrating Lymphocyte Cell Therapy and Aldesleukin for Patients with Advanced Stage Ovarian Cancer as Initial Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying ovarian carcinoma, which is a type of cancer that affects the ovaries, as well as related cancers of the fallopian tubes or the lining of the abdominal cavity. The study includes patients who have been newly diagnosed with advanced stage disease. The treatment being tested involves two main components: TIL cells, which are special immune cells called T-cells that are collected from the patient's own tumor tissue, grown in large numbers in a laboratory, and then given back to the patient through an infusion into the vein, and aldesleukin, which is a substance that helps support and activate these immune cells and is given at a low dose.

The purpose of this study is to assess the safety of this treatment combination by monitoring for serious side effects and determining the best dose to use in future studies. The trial is designed as a first-line treatment approach given before surgery, meaning it is intended to shrink the tumors before they are removed. Patients will first have tumor tissue collected so that the TIL cells can be prepared. After the cells are ready, they will be given back to the patient through infusion, followed by treatment with low-dose aldesleukin to help the immune cells work better against the cancer.

During the study, doctors will carefully monitor patients for any side effects related to the treatment, paying special attention to serious reactions. The study will also examine how the treatment affects different types of immune cells in the body and whether it helps control the cancer. This research aims to determine whether this immune-based treatment approach is safe enough to be tested more widely in patients with advanced ovarian cancer who are not initially suitable for surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Tumor tissue will be collected from your body at the beginning of the study. This tissue is needed to isolate and grow special immune cells called TIL cells (tumor-infiltrating lymphocytes), which are cells that naturally fight cancer.
These cells will be prepared in a laboratory for later use in your treatment.
Step 2
Standard chemotherapy treatment
You will receive standard chemotherapy treatment with two medications: carboplatin and paclitaxel.
This treatment is given before surgery as part of standard care for your condition.
The exact dosage, frequency, and duration will be determined by your doctor based on standard medical practice.
Step 3
TIL cell infusion
You will receive an infusion of the TIL cells that were grown from your own tumor tissue.
An infusion means the cells will be given to you through a vein, similar to an intravenous drip.
The specific dosage will be determined during the study based on safety assessments.
Step 4
Aldesleukin treatment
After receiving the TIL cells, you will be given aldesleukin, also known as IL-2 (interleukin-2), in a low dose.
Aldesleukin is a medication that helps your immune system work better and supports the TIL cells in fighting cancer.
This medication will also be given through an infusion into a vein.
The specific dosage, frequency, and duration will be determined during the study.
Step 5
Monitoring and follow-up
Throughout the study, your health will be monitored regularly to check for any side effects and to assess how the treatment is working.
Blood tests will be performed to monitor various health indicators, including blood cell counts, kidney function, and liver function.
Your disease status will be assessed using imaging tests or blood markers such as CA125, which is a protein that can indicate ovarian cancer activity.
Any side effects will be recorded and managed according to standard medical guidelines.

Who can join the trial?

11 criteria

You must be at least 18 years old or older on the day you sign the consent form
If you are able to have children, you must agree to use a very reliable method of birth control or not have sexual intercourse during the study and for at least 7 months after receiving the last dose of study treatment
You must have a confirmed diagnosis through tissue examination of a specific type of cancer called epithelial high-grade ovarian cancer, which includes cancer of the ovary, fallopian tube (the tubes connecting the ovaries to the uterus), or the lining of the abdomen, with certain cell types including serous, endometrioid, clear cell, carcinosarcoma, or mucinous
You must be newly diagnosed with FIGO Stage III (for a specific group only) or Stage IV cancer, which means the cancer has spread to certain areas of the body
Your doctor must consider you suitable to receive chemotherapy with carboplatin and paclitaxel (two cancer medications) before surgery, and you must not be considered suitable for surgery right away
It must be possible to collect a sample of your tumor tissue for special laboratory processing to grow immune cells called TIL
You must have cancer that is growing and can be measured on scans, or you must have a blood test showing CA125 (a cancer marker in the blood) that is more than 2 times the normal upper limit within the last 3 months, and this must be confirmed
You must have an ECOG performance status of 0 or 1, which means you are able to carry out normal activities with little or no symptoms
Within the last 4 weeks before starting the study, your blood tests must show: Hemoglobin (red blood cells) at least 6.0 mmol/l, Granulocytes (a type of white blood cell) at least 1,500 per microliter, Lymphocytes (another type of white blood cell) at least 700 per microliter, Platelets (blood clotting cells) at least 100,000 per microliter, Creatinine clearance (kidney function test) at least 50 ml per minute, Serum bilirubin (liver function marker) no more than 40 micromol/l, ASAT and ALAT (liver enzymes) no more than 5 times the normal upper limit
You must have negative tests for certain viruses including HIV (human immunodeficiency virus) types 1 and 2, HTLV (human T-cell lymphotropic virus), and TPHA (syphilis test), and you must not have hepatitis B virus antigen or antibodies, and you must not have antibodies against hepatitis C virus
You must be able and willing to provide written permission to participate in the study after understanding all the information provided

Who cannot join the trial?

4 criteria

The data provided does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the study
This study is only for female patients, so male patients cannot participate
The study focuses on patients with ovarian carcinoma, which is a type of cancer that starts in the ovaries (the organs in women that produce eggs)
The study appears to have specific age requirements, though the exact age ranges are not clearly defined in the provided information

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Verified sites

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Leids Universitair Medisch Centrum (LUMC)
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Leiden, The Netherlands

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Investigated drugs

Adoptive T cell therapy
is a treatment that uses special immune cells called T cells. These cells are collected from the patient's own tumor tissue, grown in large numbers in a laboratory, and then given back to the patient through an infusion. The goal is to help the patient's immune system recognize and attack cancer cells more effectively.
IL-2
(also known as Interleukin-2) is a protein that helps the immune system work better. In this trial, it is given in low doses to support the T cells that were given to the patient. It helps the T cells survive longer and work more effectively against the cancer.

TIL CELLS

What is already known about the treatment

Adoptive T Cell Therapy
This is an experimental cancer treatment that involves collecting immune cells called T cells from a patient's tumor, growing them in large numbers in a laboratory, and then infusing them back into the patient's bloodstream to help fight cancer. In this clinical trial, it is being tested as a first-line treatment before surgery for advanced ovarian cancer patients, combined with low-dose IL-2 to enhance the immune response. The therapy works by using the body's own immune cells that have been specially selected because they can recognize and attack cancer cells, then multiplying them outside the body to create a powerful army of cancer-fighting cells. This approach falls under the category of immunotherapy, which aims to strengthen the patient's immune system to better combat cancer.
Interleukin-2 (IL-2)
This is a naturally occurring protein in the body that helps regulate immune system function and is used as a medication to boost the immune response against cancer. In this study, it is being given at low doses alongside adoptive T cell therapy to support and activate the infused immune cells, helping them survive longer and work more effectively against ovarian cancer. IL-2 works at the molecular level by binding to specific receptors on T cells and other immune cells, triggering signals that promote their growth, multiplication, and ability to kill cancer cells. This medication belongs to the class of biological response modifiers or immunostimulants, which are substances that enhance the body's natural defense mechanisms.

Investigated diseases

Ovarian Carcinoma – Ovarian carcinoma is a type of cancer that develops in the ovaries, which are the female reproductive organs that produce eggs. The disease begins when cells in the ovary start to grow abnormally and multiply out of control. As the cancer progresses, it can spread beyond the ovary to other parts of the pelvis and abdomen. In early stages, ovarian carcinoma may not cause noticeable symptoms, making it difficult to detect. As it advances, symptoms may include abdominal bloating, pelvic pain, difficulty eating, and frequent urination. The cancer can continue to grow and affect nearby organs and tissues if left untreated.