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Complete 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
|Research Study Number||2705.00|
|Principal Investigator||Seth Pollack|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma
- All patients must have consulted with a surgical provider and are being considered for resection or biopsy of their tumor
- Available prior biopsy or tumor resection specimen of lesion to be resected (the target lesion) or biopsied confirming the diagnosis of that lesion and with tissue available for class I MHC staining
- Zubrod performance status of '0-2'
- No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma
- Patients must have an electrocardiogram (EKG) performed within 2 weeks of enrollment; patients with a history of cardiac disease or abnormal EKG 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
- Untreated 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) > 150/100mmHg; patients with elevated BP may enroll once BP is corrected
- Prior cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy
Other exclusion criteria may apply.
Sarcoma; Solid Tumors
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