Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT01957709|
Recruitment Status : Terminated (Enough samples were collected for data analysis.)
First Posted : October 8, 2013
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myxoid Liposarcoma Round Cell Liposarcoma Synovial Sarcoma||Other: Laboratory Biomarker Analysis Biological: Recombinant Interferon Gamma||Early Phase 1|
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.
After completion of study, patients are followed up at 2 weeks post-surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||100 mcg/m2 weekly injection for four weeks|
|Masking:||None (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|
|Actual Study Start Date :||September 25, 2013|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
Experimental: Basic science (interferon gamma and MHC expression)
Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.
Other: Laboratory Biomarker Analysis
Biological: Recombinant Interferon Gamma
Given subcutaneously weekly for four weeks prior to surgery.
- Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma [ Time Frame: Baseline to up to 2 weeks post-surgery ]It would be highly relevant to observe marked increase macrophages (effect size > 2.5). Four patients gives over 90% power to detect such a large increase with a two-tailed alpha of 0.05.
- MHC Class II Expression [ Time Frame: Baseline to 2 weeks post biopsy. ]To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors.
- Changes in Immune Response [ Time Frame: Baseline to 2 weeks post biopsy ]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 IFNg treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957709
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Seth Pollack||Fred Hutch/University of Washington Cancer Consortium|