Clinical trial NCT01957709: Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Myxoid Liposarcoma
Round Cell Liposarcoma
Synovial Sarcoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Horizon Pharma USA, Inc.
First posted: 2013-10-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 100 mcg/m2 weekly injection for four weeks
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma
timeFrame: Baseline to up to 2 weeks post-surgery
Secondary outcomes:
measure: MHC Class II Expression
timeFrame: Baseline to 2 weeks post biopsy.
measure: Changes in Immune Response
timeFrame: Baseline to 2 weeks post biopsy
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Seth Pollack
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.