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Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

Primary Purpose

Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial Sarcoma

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Laboratory Biomarker Analysis

Recombinant Interferon Gamma

About this trial

This is an interventional basic science trial for Myxoid Liposarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma
Male or female subject, 18 or older
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
Significant hepatic dysfunction (SGOT > 150 IU or > 3x upper limit of normal; bilirubin > 1.6 mg/dL; prothrombin time > 1.5x 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.

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Basic science (interferon gamma and MHC expression)

Arm Description

Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MHC Class II Expression

To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors.

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.

Full Information

NCT ID

NCT01957709

First Posted

October 4, 2013

Last Updated

June 19, 2019

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI), Horizon Pharma USA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01957709

Brief Title

Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

Enough samples were collected for data analysis.

Study Start Date

September 25, 2013 (Actual)

Primary Completion Date

June 1, 2018 (Actual)

Study Completion Date

June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI), Horizon Pharma USA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial Sarcoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

100 mcg/m2 weekly injection for four weeks

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Basic science (interferon gamma and MHC expression)

Arm Type

Experimental

Arm Description

Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Intervention Type

Biological

Intervention Name(s)

Recombinant Interferon Gamma

Other Intervention Name(s)

Gamma Interferon (GEN), Gamma Interferon-SCH, Gamma-Interferon, Ginterferon, IFN-g, Interferon Gamma, Interferon Gamma (BIO), Interferon, Gamma

Intervention Description

Given subcutaneously weekly for four weeks prior to surgery.

Primary Outcome Measure Information:

Title

Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma

Description

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.

Time Frame

Baseline to up to 2 weeks post-surgery

Secondary Outcome Measure Information:

Title

MHC Class II Expression

Description

To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors.

Time Frame

Baseline to 2 weeks post biopsy.

Title

Changes in Immune Response

Description

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.

Time Frame

Baseline to 2 weeks post biopsy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma Male or female subject, 18 or older 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 Significant hepatic dysfunction (SGOT > 150 IU or > 3x upper limit of normal; bilirubin > 1.6 mg/dL; prothrombin time > 1.5x 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seth Pollack

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32269142

Citation

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.

Results Reference

derived

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Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

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