Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

Early Phase 1

Terminated

• Conditions: Myxoid Liposarcoma; Synovial Sarcoma; Round Cell Liposarcoma
• Interventions: Other: Laboratory Biomarker Analysis; Biological: Recombinant Interferon Gamma

• Registration Number: NCT01957709
• Lead Sponsor: Fred Hutchinson Cancer 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.

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 Timeline

• Study Start: 2013-09-25
• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-08
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Results First Submitted: 2019-05-28
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Results First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basic science (interferon gamma and MHC expression)	Recombinant Interferon Gamma	Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.
Basic science (interferon gamma and MHC expression)	Laboratory Biomarker Analysis	Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.

Primary Outcome Measures

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

Name	Time	Method
Changes in Immune Response	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.
MHC Class II Expression	Baseline to 2 weeks post biopsy.	To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States