Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

NCT ID: NCT01957709

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-25
• Study Completion Date: 2018-06-01

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.

Conditions

Myxoid Liposarcoma; Round Cell Liposarcoma; Synovial Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Basic science (interferon gamma and MHC expression)

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

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Recombinant Interferon Gamma

Intervention Type: BIOLOGICAL

Given subcutaneously weekly for four weeks prior to surgery.

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Recombinant Interferon Gamma

Given subcutaneously weekly for four weeks prior to surgery.

Intervention Type: BIOLOGICAL

Other Intervention Names

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

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Horizon Pharma USA, Inc.

INDUSTRY

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seth Pollack

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32269142 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2013-01779

Identifier Type: REGISTRY

Identifier Source: secondary_id

2705

Identifier Type: OTHER

Identifier Source: secondary_id

2705.00

Identifier Type: OTHER

Identifier Source: secondary_id

K12CA076930

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23CA175167

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2705.00

Identifier Type: -

Identifier Source: org_study_id