A Study of Anti-CTLA4 Antibody in People With Advanced Synovial Sarcoma
Drug: Anti-CTLA4 (monoclonal antibody MDX-010)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Anti-CTLA4 Antibody in Advanced Synovial Sarcoma Patients|
- 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]).
- To determine the clinical benefit rate (CR + PR + stable disease [SD]) of patients with advanced synovial sarcoma following treatment with anti-CTLA4.
- To evaluate NY-ESO-1 specific immunity (NY-ESO-1 and LAGE-1 antibody, CD8+ and CD4+ T cells, and delayed-type hypersensitivity [DTH]) induced by three doses of anti-CTLA4 antibody in patients with synovial sarcoma.
- To determine the safety of anti-CTLA4 in patients with synovial sarcoma.
|Study Start Date:||July 2005|
|Study Completion Date:||April 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140855
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Robert G Maki, MD PhD||Memorial Sloan Kettering Cancer Center|