Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Terminated

Early Phase 1

Conditions

Myxoid Liposarcoma

Round Cell Liposarcoma

Synovial Sarcoma

Treatments

Other: Laboratory Biomarker Analysis

Biological: Recombinant Interferon Gamma

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT01957709

2705.00 (Other Identifier)

K12CA076930 (U.S. NIH Grant/Contract)

NCI-2013-01779 (Registry Identifier)

2705

P30CA015704 (U.S. NIH Grant/Contract)

K23CA175167 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.