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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| K23CA175167 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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Enough samples were collected for data analysis.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Horizon Pharma USA, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic science (interferon gamma and MHC expression) | Experimental | Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma | 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. | Baseline to up to 2 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| MHC Class II Expression | To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors. | Baseline to 2 weeks post biopsy. |
| Changes in Immune Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Pollack | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32269142 | Derived | Schroeder BA, Black RG, Spadinger S, Zhang S, Kohli K, Cao J, Mantilla JG, Conrad EU, Riddell SR, Jones RL, Yee C, Pollack SM. Histiocyte predominant myocarditis resulting from the addition of interferon gamma to cyclophosphamide-based lymphodepletion for adoptive cellular therapy. J Immunother Cancer. 2020 Apr;8(1):e000247. doi: 10.1136/jitc-2019-000247. |
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Recruitment was done in the Seattle Cancer Care Alliance medical clinic, or by patient referral.
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| ID | Title | Description |
|---|---|---|
| FG000 | Basic Science (Interferon Gamma and MHC Expression) | Patients receive recombinant interferon gamma SC weekly for 4 weeks before surgery. Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Gamma: Given Subcutaneously |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Gamma: Given SC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma | 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. | Posted | Median | Full Range | percentage of MHC Class I+ on tumor cell | Baseline to up to 2 weeks post-surgery |
|
|
Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Gamma: Given SC |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1: all events |
Early termination of trial due to collection of enough data necessary to complete analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seth Pollack, MD | Fred Hutchinson Cancer Research Center | 206-667-6629 | spollack@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2018 | May 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018208 | Liposarcoma, Myxoid |
| D013584 | Sarcoma, Synovial |
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007371 | Interferon-gamma |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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100 mcg/m2 weekly injection for four weeks
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| Recombinant Interferon Gamma | Biological | Given subcutaneously weekly for four weeks prior to surgery. |
|
|
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.
| Baseline to 2 weeks post biopsy |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | MHC Class II Expression | To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors. | Posted | Median | Full Range | percentage of MHC Class II on tumor cell | Baseline to 2 weeks post biopsy. |
|
|
|
| Secondary | Changes in Immune Response | 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. | Posted | Median | Full Range | percentage of T cells | Baseline to 2 weeks post biopsy |
|
|
|
| 7 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1: 4 events Grade 2: 1 event |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1: all events |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 1: all events |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1: all events |
|
| Body Aches | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1: all events |
|
| Injection site pain | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1: all events |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| Night Sweats | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Injection site erythema | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
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| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Biopsy site pain | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
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| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D009372 | Neoplasms, Connective Tissue |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |