Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
|Myxoid Liposarcoma Round Cell Liposarcoma Synovial Sarcoma||Other: Laboratory Biomarker Analysis Biological: Recombinant Interferon Gamma|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Pilot Study to Test Whether Systemic Interferon Gamma Increases Tumor Class I MHC Expression in Patients With Synovial Sarcoma and Myxoid/Round Cell Liposarcoma|
- Change in class I MHC expression after treatment with IFN gamma as determined by immunohistochemistry (IHC) [ Time Frame: Baseline to up to 2 weeks post-surgery ]It is estimated that the true mean change in expression following IFN gamma will be 50% (for homogenous expression) with a standard deviation of 30%. Seven patients will provide 95% power to observe a change in expression (before IFN vs. after IFN) that is statistically significantly (at the 2-sided significance level of .05) different from a change of zero.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: Basic science (interferon gamma and MHC expression)
Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
Other: Laboratory Biomarker Analysis
Correlative studiesBiological: Recombinant Interferon Gamma
I. To determine whether systemic administration of interferon (IFN) gamma (recombinant interferon gamma) will increase class I major histocompatibility complex (MHC) expression in synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCL) tumors.
I. To determine whether systemic administration of IFN gamma will increase class II MHC expression in SS and MRCL tumors.
II. To examine changes in the immune response to MRCL and SS by examining changes in the immune infiltrates, antibody response and antigen specific T cell response before and after IFN gamma treatment.
Patients receive recombinant interferon gamma subcutaneously (SC) every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
After completion of study, patients are followed up at 2 weeks post-surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01957709
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Seth Pollack 206-667-6629 firstname.lastname@example.org|
|Principal Investigator: Seth Pollack|
|Principal Investigator:||Seth Pollack||Fred Hutch/University of Washington Cancer Consortium|