By Sara Bondell
Despite the great advances in oncology over the past decade and the development of targeted therapies, lack of effective treatment options is a critical issue in sarcomas — cancers that arise in bones, fat and muscle — especially for advanced tumors and those that have spread.
Chemotherapy is most often the treatment recommended for these patients with advanced disease, but many times the standard regimens do not offer a durable response for patients with sarcoma.
Moffitt Cancer Center has been a leader in offering immunotherapy as another treatment option for sarcomas. Now, our Sarcoma Oncology Program is the first in the country to open a sarcoma adoptive cell therapy clinical trial solely focused on sarcoma patients receiving an infusion of tumor infiltrating lymphocytes (TIL).
“TIL trials were pioneered by the Surgery Branch at the National Cancer Institute and have resulted in some dramatic responses for patients with advanced melanoma, many of which are durable,” said surgical oncologist Dr. John Mullinax, who is the principal investigator for the trial. “We are proud to have developed a novel strategy in the Moffitt sarcoma research laboratory to expand TIL from melanoma. This allows us to treat sarcoma patients with the TIL therapy, and we are optimistic about similar results for these patients.”
The trial will enroll five Adolescent and Young Adult (AYA) patients ages 18-39 with metastatic sarcoma that have failed at least one other standard treatment therapy.
What is TIL?
Cancer finds ways to disarm and elude the immune system, but recent advances in treatment can now overcome this evasion. This type of therapy is broadly called immunotherapy, and the cells most often targeted for enhanced response are white blood cells called T lymphocytes. TIL therapy involves techniques to grow the tumor infiltrating lymphocytes outside the body, thereby allowing for recovery of the anti-tumor function. Once grown to large numbers, the physicians infuse these activated tumor infiltrating lymphocytes back into the patient. Moffitt’s Cell Therapies facility can generate the TIL product onsite for Moffitt patients and others across the country.
“At the time of infusion, we will effectively ‘swap’ a patient’s peripheral, circulating immune system with one that is tumor-responsive,” said Mullinax. “While the patient’s ‘normal’ immune system will recover over the subsequent weeks, the TIL we infuse has been shown in other studies to persist long after infusion. Most encouraging is that for many of those melanoma patients with a response, it’s a durable response that can last years.”
TIL therapy has proved very successful in clinical trials with melanoma patients both at Moffitt and other institutions. It is currently on the fast-track list for Food and Drug Administration approval. Mullinax is hoping to see the same success in sarcoma patients as has been seen for melanoma patients at Moffitt.
AYA Clinical Trials
The trial is specifically geared toward the adolescent and young adult (AYA) population. In the United States, AYA patients have the lowest clinical trial participation rate of all age groups and slower progress in survival improvement than younger patients. AYA patients also have the lowest proportion of specimens available for research.
“What is so exciting about this trial is that we are bringing an extraordinarily promising and personalized therapy to a rare population,” said Dr. Damon Reed, Moffitt’s Adolescent and Young Adult Program leader. “These patients will be among the first to potentially realize the benefit of this type of therapy rather than waiting years after other cancers.”