Tumor Infiltrating Lymphocyte Therapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests the effect of autologous tumor infiltrating lymphocytes (TILs) in combination with interleukin-2 (aldesleukin) in treating patients with gastrointestinal stromal tumors (GIST) that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Autologous TILs are made using the patient's own tumor cells collected from a previous surgery. Lymphocytes (a type of white blood cell) are a part of the immune system that helps the body fight infections. Lymphocytes are found in tumor tissue cells because they are working to attack the tumor. The cells from the tumor are grown in a lab to create more immune cells (lymphocytes). This may help the immune system find and destroy any remaining tumor cells. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes, that is made in the laboratory. Aldesleukin may help white blood cells and T cells regulate the immune response. Chemotherapy, such as cyclophosphamide and fludarabine, are given before receiving TIL to help kill tumor cells in the body and helps make room for the treatment. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving autologous TILs in combination with aldesleukin may be safe, tolerable, and/or effective in treating patients with locally advanced, recurrent or metastatic GIST.
Who Is on the Research Team?
Joal Beane, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with gastrointestinal stromal tumors (GIST) that have spread, come back after treatment, or are locally advanced. Participants must be able to undergo surgery and other study procedures.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Aldesleukin
- Cyclophosphamide
- Filgrastim
- Fludarabine
- Tumor Infiltrating Lymphocyte Therapy
Trial Overview
The study tests using a patient's own immune cells (TILs), grown from their tumor, combined with interleukin-2 (aldesleukin). Before this, patients get chemotherapy to prepare the body. The goal is to see if this approach helps fight GIST.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive cyclophosphamide IV over 2 hours on days -8 and -7, fludarabine IV over 30 minutes on days -6 to -2 and TIL IV over 20-30 minutes on day 0 in the absence of disease progression or unacceptable toxicity. Starting within 24 hours of TIL infusion, patients receive aldesleukin IV over 15 minutes every 8 hours for up to 6 doses on days 0-3 in the absence of disease progression or unacceptable toxicity. Starting on day 1 or day 2, patients may receive filgrastim SC until neutrophil count \> 1 x 10\^9/L for 3 consecutive days or \> 5 x 10\^9/L. Patients with stable disease, partial response or recurrence may receive a second course of treatment. Patients also undergo chest x-ray at screening and urine and blood sample collection, CT, MRI or PET throughout the study. Additionally, patients may also undergo echocardiography or MUGA at screening and may also undergo a second surgery to collect cells on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joal Beane
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.