Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01957709|
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myxoid Liposarcoma Round Cell Liposarcoma Synovial Sarcoma||Other: Laboratory Biomarker Analysis Biological: Recombinant Interferon Gamma||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Estimated Primary Completion Date :||October 1, 2018|
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
- Change in class I major histocompatibility complex (MHC) expression after treatment with IFN gamma as determined by immunohistochemistry (IHC) [ 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.
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||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|