Clinical Trial: Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: This pilot clinical trial studies the effect of recombinant interferon gamma on tissue in treating patients with soft tissue sarcoma. Interferon gamma may interfere with the growth of tumor cells.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: October 4, 2013
Date Started: September 2013
Date Completion:
Last Updated: October 14, 2016
Last Verified: October 2016