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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. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Horizon Pharma USA, Inc.
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

Study Description
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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 Early Phase 1

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.

After completion of study, patients are followed up at 2 weeks post-surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Basic science (interferon gamma and MHC expression)
Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.
 Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Recombinant Interferon Gamma
Given subcutaneously weekly for four weeks prior to surgery.
Other Names:
  • Gamma Interferon (GEN)
  • Gamma Interferon-SCH
  • Gamma-Interferon
  • Ginterferon
  • IFN-g
  • Interferon Gamma
  • Interferon Gamma (BIO)
  • Interferon, Gamma


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  1. A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma
  2. Male or female subject, 18 or older
  3. 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.
  4. Zubrod performance status of '0-2' or Karnofsky score > 60%
  5. No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma
  6. Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma
  7. Must have been off metformin for at least 2 weeks prior to starting IFN gamma
  8. No use of full dose, therapeutic anti-coagulation. However, low dose warfarin for catheter prophylaxis or acetylsalicylic acid are acceptable.
  9. No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of starting IFN gamma

Exclusion Criteria:

  1. Active infection requiring oral or intravenous antibiotics
  2. 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.
  3. Serum creatinine > 1.5 mg/dL or Glomerular Filtration Rate < 50
  4. Significant hepatic dysfunction (SGOT > 150 IU or > 3x upper limit of normal; bilirubin > 1.6 mg/dL; prothrombin time > 1.5x control).
  5. Known central nervous system (CNS) metastasis. Once CNS metastasis have been treated these patients may participate if they are otherwise good trial candidates.
  6. Current treatment with steroids (must be discontinued 1 week before starting IFN gamma)
  7. Hemoglobin A1C > 8.5%
  8. Uncontrolled hypertension, blood pressure (BP) > 150/100 mmHg; patients with elevated BP may enroll once BP is corrected
  9. Cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy within 1 year of starting on the trial
  10. New (< 6 months) cardiac arrhythmia (electrocardiogram [EKG] should be performed within 2 weeks of starting IFN gamma).
  11. History of clinically significant congestive heart failure.
Contacts and Locations
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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
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Horizon Pharma USA, Inc.
Investigators
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Principal Investigator: Seth Pollack Fred Hutch/University of Washington Cancer Consortium
  Study Documents (Full-Text)

Documents provided by Fred Hutchinson Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] September 12, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT01957709    
Other Study ID Numbers: 2705.00
NCI-2013-01779 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2705 ( Other Identifier: Fred Hutchinson Cancer Research Center )
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
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sarcoma
Liposarcoma
Sarcoma, Synovial
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