This phase 2 trial is examining the effectiveness of tumor-infiltrating lymphocytes (TIL) in the treatment of colorectal cancer. The main outcome to be measured is the tumor response to the treatment. This trial will be conducted in Texas, US.
The details
Cancer is one of the leading causes of death worldwide. Therapy such as chemotherapy or radiation therapy is only of limited effectiveness. The addition of other agents such as immunotherapy to the standard treatment improved the outcomes of cancer patients.
TIL consists in removing cells from the immune system that are already attacking the tumor, to put them back in the tumor after being activated. This activation happens in the laboratory by giving the cells a treatment. A Large number of these activated cells are given back to the patient to help the immune system fight the cancer. This treatment might improve the outcomes of patients with cancer that has come back or did not respond to first-line treatment.
This phase 2 trial is examining the effectiveness of TILs in the treatment of colorectal cancer. The main outcome to be measured is the tumor response to the treatment.
Who are they looking for?
This trial is recruiting 60 participants with cancer, including colorectal cancer. Patients must have cancer that has come back or is not responding to treatment. These patients must have stopped therapy at least 28 days prior to this trial. Must have normal blood levels and normal heart and lung function. Patients of childbearing age must agree to use effective birth control during the study.
Participants must not have active infections, including hepatitis and HIV. Must not have a history of prior cell therapies, immune disorders, organ or cell transplant, steroid therapy, second cancer or brain metastasis. These patients must not have persistent toxicity from prior treatment, mental disorder or allergy to the TIL therapy. Must not have received a live vaccine within 30 days prior to this trial and must not be pregnant or breastfeeding.
How will it work
All patients will receive the study treatment. Patients will receive cyclophosphamide (Cytoxan) over 2 hours on days 7 and 6 before TILs. Then, patients will receive fludarabine (Fludara) over 30 minutes on days 5 and 1 before TILs. After this, patients will receive TIL over 45 minutes on day 0 which will be followed by Interleukin-2 over 30 minutes on days 1 to 4 for up to 6 or until progression or toxicity.
After the treatment patients will be followed up at week 18, at 6, 9, 12, 18 and 24 months, and then every 3 months for up to 3 years.
