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Study on the Effectiveness of Autologous Tumor-Infiltrating Lymphocytes, Aldesleukin, Fludarabine Phosphate, and Cyclophosphamide in Advanced Solid Tumors

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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 focused on studying advanced solid tumors, which are types of cancer that have spread and are difficult to remove with surgery. The study is investigating a treatment using Tumor Infiltrating Lymphocytes (TILs), which are special immune cells taken from a patient's own tumor. These cells are grown in large numbers in a lab and then given back to the patient to help fight the cancer. The purpose of the study is to evaluate how effective this treatment is for patients with advanced tumors that have specific genetic changes in the SWI/SNF complex, a group of proteins that help control the way genes are turned on and off in cells.

In addition to TILs, the study involves other medications that may be used in combination with the TILs treatment. These include Aldesleukin, a drug that helps boost the immune system; Fludarabine Phosphate, a chemotherapy drug that helps prepare the body for TILs; and Cyclophosphamide Monohydrate, another chemotherapy drug used to suppress the immune system before TILs are given. Some patients may receive a placebo as part of the study to compare the effects of the actual treatment.

The study will take place over several weeks, during which patients will receive the TILs treatment and other medications through an intravenous (IV) infusion, which means the drugs are given directly into a vein. Patients will be monitored closely by doctors to see how their tumors respond to the treatment and to check for any side effects. The study aims to provide valuable information on the potential benefits and risks of using TILs to treat advanced solid tumors with specific genetic changes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm the diagnosis of advanced solid tumors with specific genetic alterations. This includes a review of medical history and previous treatments.
Step 2
Preparation phase
A washout period is required from any prior cancer treatments. This period lasts at least 21 days for chemotherapy and immunotherapy, and at least 14 days for radiation therapy, ensuring that any side effects are resolved.
Step 3
Treatment initiation
The treatment begins with the administration of fludarabine phosphate and cyclophosphamide monohydrate through intravenous infusion. These medications help prepare the body for the main treatment by reducing the number of existing immune cells.
Step 4
Main treatment
The main treatment involves the infusion of autologous tumor-infiltrating lymphocytes (TILs). These are special immune cells that have been extracted, multiplied, and prepared to target the tumor cells more effectively.
Step 5
Supportive therapy
Following the TILs infusion, aldesleukin is administered through intravenous infusion. This medication supports the activity of the infused TILs, enhancing their ability to attack the tumor cells.
Step 6
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes physical examinations, laboratory tests, and imaging studies to evaluate the tumor's response.

Who can join the trial?

17 criteria

Patients must have a confirmed diagnosis of **solid tumors**. These are types of cancer that form in solid organs or tissues, not in the blood.
The solid tumors must be associated with **SWI-SNF complex mutations**. This is a specific change in the genes that can affect how cells grow.
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Examples of these tumors include:
- Epithelioid sarcoma
- Malignant rhabdoid tumor
- Small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)
- Renal medullary carcinoma
- Epithelioid malignant peripheral nerve sheath tumor (EMPNST)
- Myoepithelial carcinoma
- Extra-skeletal myxoid chondrosarcoma
- Poorly differentiated chordoma
- Sinonasal basaloid carcinoma
- Patients must have a **measurable disease**. This means the cancer can be measured in size using specific criteria called RECIST 1.1.
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  Patients must have a **washout period** from previous cancer treatments. This means they need to wait a certain amount of time after their last treatment before starting the study treatment:
  - For chemotherapy, the wait is at least 21 days.
  - For immunotherapy or other similar treatments, the wait is also at least 21 days.
  - Patients who had **palliative radiation therapy** must wait at least 2 weeks before starting the study treatment. Palliative radiation is used to relieve symptoms, not to cure the cancer.
  - Both **men and women** can participate in the study.
  - The study includes people from **vulnerable populations**. This means it may include people who need special protection or care.

Who cannot join the trial?

10 criteria

Patients who have had another type of cancer in the past, unless it was a type that is not expected to come back.
Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
Patients who have a serious heart condition, such as heart failure or a recent heart attack.
Patients who have a serious lung condition, such as severe asthma or chronic obstructive pulmonary disease (COPD).
Patients who have a serious liver condition, such as cirrhosis or active hepatitis.
Patients who have a serious kidney condition, such as kidney failure.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to any of the components of the treatment being studied.
Patients who are participating in another clinical trial or have received another investigational treatment within a certain period before this study.
Patients who have a condition that, in the opinion of the study doctor, would make it unsafe for them to participate in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Verified
Hospital Vall d’Hebron
Barcelona, Spain
Verified
Institut Catala D'oncologia
L'hospitalet De Llobregat, Spain

Trial locations

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Investigated drugs

VHIO-TIL-01 is a therapy that uses a patient's own immune cells, known as tumor-infiltrating lymphocytes (TILs), to treat advanced tumors. These immune cells are collected from the patient's tumor, grown in large numbers in a laboratory, and then infused back into the patient. The goal is to help the immune system recognize and attack cancer cells more effectively. This treatment is being studied for its potential to improve outcomes in patients with tumors that have specific genetic changes in the SWI-SNF complex, which can make the cancer more difficult to treat with standard therapies.

What is already known about the treatment

VHIO-TIL-01 – This medication is administered through infusion and is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for VHIO-TIL-01 is for patients with unresectable or advanced tumors that have specific genetic alterations. The mechanism of action involves using the patient's own immune cells, known as tumor-infiltrating lymphocytes (TILs), which are expanded and activated outside the body to target and destroy cancer cells. VHIO-TIL-01 falls under the pharmacological classification of immunotherapy, specifically a form of adoptive cell transfer therapy.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that have progressed to a stage where they are no longer confined to their original location and may have spread to other parts of the body. These tumors are characterized by their ability to grow uncontrollably and invade surrounding tissues. As they advance, they can cause symptoms related to the affected organs and may lead to complications due to their size and location. The progression of these tumors can vary depending on the type of cancer and its biological behavior. They are often resistant to standard treatments, making management challenging. The focus is typically on controlling growth and alleviating symptoms.