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Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT01957709
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Horizon Pharmaceuticals
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Myxoid Liposarcoma Round Cell Liposarcoma Synovial Sarcoma Other: Laboratory Biomarker Analysis Biological: Recombinant Interferon Gamma Not Applicable

Detailed Description:

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.


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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) > 150/100 mmHg; 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

Information from the National Library of Medicine

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


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Seth Pollack    206-667-6629    spollack@seattlecca.org   
Principal Investigator: Seth Pollack         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Horizon Pharmaceuticals
Investigators
Principal Investigator: Seth Pollack Fred Hutch/University of Washington Cancer Consortium

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01957709     History of Changes
Other Study ID Numbers: 2705.00
NCI-2013-01779 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2705
2705.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
K12CA076930 ( U.S. NIH Grant/Contract )
K23CA175167 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Synovial
Liposarcoma
Liposarcoma, Myxoid
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents