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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. Our Sarcoma Department 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 involves techniques to grow the tumor-infiltrating lymphocytes outside the body, allowing for recovery of the anti-tumor function. Once grown to large numbers, these activated tumor-infiltrating lymphocytes are infused back into the patient.

John Mullinax, M.D., Sarcoma Department

Dr. John Mullinax, Sarcoma Department

“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 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.

The results of the trial were presented at the annual Connective Tissue Oncology Society Annual Meeting in Ireland in November 2023. The results showed 71% of the patients enrolled were successfully treated and TIL therapy stalled disease progression in all treated patients to varying degrees. One patient on the trial is still showing a durable response more than a year after infusion. The trial accomplished its goal to prove that TIL is safe and feasible for sarcoma patients. 

TIL was approved by the Food and Drug Administration for melanoma in February 2024. Mullinax is hoping to see the same success in sarcoma patients as has been seen for melanoma patients at Moffitt.