Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

Stopped early · Early Phase 1

Conditions studied: Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial Sarcoma

In brief

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.

Key facts

Study ID

NCT01957709

Run by

Fred Hutchinson Cancer Center

People needed

8

Starts

2013-09-25

Expected to finish

2018-06-01

Last updated by the study team

2019-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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