Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

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 or thrice weekly for 2 weeks before surgery.

After completion of study, patients are followed up at 2 weeks post-surgery.

Inclusion Criteria:

- A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma

- 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

- Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3 x upper limit of normal

- Bilirubin > 1.6 mg/dL

- Prothrombin time > 1.5 x 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