A Phase II Study of Anti-CTLA4 Antibody in Advanced Synovial Sarcoma Patients
Approximately 750-900 people in the United States each year develop synovial sarcoma, a rare
form of cancer of connective tissue. This tumor frequently metastasizes to other parts of
the body such as the lungs. Chemotherapy can sometimes decrease the size of the recurrent
tumors, but these results are usually only temporary, and the tumors grow again.
We are trying to exploit some of the proteins made by synovial sarcoma (cancer-germ cell or
cancer-testis antigens) as targets for the immune system. Specifically, we are investigating
if immune-based therapy with anti-CTLA4 antibody once every 4 weeks for three treatments
will activate the immune system enough to attack recurrent synovial sarcoma. In this study
the tumor itself serves as the "vaccine" or source of protein, as we try to activate
tumor-fighting T cells with the anti-CTLA4.
Anti-CTLA4 takes the brakes off the immune system to allow otherwise hidden immune responses
to become more active. In so doing, there could be other side effects, such as immune system
attacks against the normal organs of the body. We will follow both the anti-tumor immune
responses with frequent blood tests and follow and treat side effects people develop on this
study to determine if anti-CTLA4 is worth pursuing in a larger number of patients with
synovial sarcoma or other sarcomas.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the clinical response of patients with advanced synovial sarcoma following treatment with anti-CTLA4 (RECIST-defined complete response [CR] and partial response [PR]).
Robert G Maki, MD PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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