Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

Synovial Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01957709
• Other study ID #: 2705.00
• Secondary ID: NCI-2013-0177927
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 25, 2013
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2019
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liposarcoma
• Liposarcoma, Myxoid
• Myxoid Liposarcoma
• Round Cell Liposarcoma
• Sarcoma
• Sarcoma, Synovial
• Synovial Sarcoma

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Biological:
• Recombinant Interferon Gamma
Given subcutaneously weekly for four weeks prior to surgery.

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Horizon Pharma USA, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to up to 2 weeks post-surgery
Secondary	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.
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.	Baseline to 2 weeks post biopsy