Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center Identifier:
First received: October 4, 2013
Last updated: October 15, 2015
Last verified: October 2015
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.

Condition Intervention
Myxoid Liposarcoma
Round Cell Liposarcoma
Synovial Sarcoma
Other: Laboratory Biomarker Analysis
Biological: Recombinant Interferon Gamma

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
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

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 12
Study Start Date: September 2013
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 studies
Biological: Recombinant Interferon Gamma
Given SC
Other Names:
  • Gamma Interferon (GEN)
  • Gamma Interferon-SCH
  • Gamma-Interferon
  • Ginterferon
  • IFN-g
  • Interferon Gamma
  • Interferon Gamma (BIO)
  • Interferon, Gamma

Detailed Description:


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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma
  • A superficial tumor easily and safely accessible for a research biopsy or are being considered for resection or biopsy of their tumor as part of standard of care and have recent pathology
  • Zubrod performance status of '0-2' or Karnofsky score > 60%
  • No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma
  • Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma
  • Must have been off metformin for at least 2 weeks prior to starting IFN gamma
  • No use of full dose, therapeutic anti-coagulation; however, low dose warfarin for catheter prophylaxis or acetylsalicylic acid are acceptable
  • No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of starting IFN gamma

Exclusion Criteria:

  • Active infection requiring oral or intravenous antibiotics
  • Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry
  • Serum creatinine > 1.5 mg/dL or glomerular filtration rate < 50
  • Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3 x upper limit of normal
  • Bilirubin > 1.6 mg/dL
  • Prothrombin time > 1.5 x control
  • Known central nervous system (CNS) metastasis; once CNS metastasis have been treated these patients may participate if they are otherwise good trial candidates
  • Current treatment with steroids (must be discontinued 1 week before starting IFN gamma)
  • Hemoglobin A1C > 8.5%
  • Uncontrolled hypertension, blood pressure (BP) > 150/100mmHg; patients with elevated BP may enroll once BP is corrected
  • Cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy within 1 year of starting on the trial
  • New (< 6 months) cardiac arrhythmia (electrocardiogram [EKG] should be performed within 2 weeks of starting IFN gamma)
  • History of clinically significant congestive heart failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01957709

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Seth Pollack    206-667-6629   
Principal Investigator: Seth Pollack         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Seth Pollack Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center Identifier: NCT01957709     History of Changes
Other Study ID Numbers: 2705.00, NCI-2013-01779, 2705, 2705.00, K12CA076930, P30CA015704
Study First Received: October 4, 2013
Last Updated: October 15, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Liposarcoma, Myxoid
Sarcoma, Synovial
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015