|Recruiting||Sarcoma; Solid Tumors||Pilot Study||
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.
- A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma
- Being considered for resection or have a lesion accessible for core needle biopsy at bedside
- Recent prior biopsy 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; "recent" in this context means that the patient may not have received any systemic anti-cancer therapy (chemotherapy or biologics) since the biopsy of the lesion or any radiation to that lesion since the biopsy
- 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
- All patients must have consulted with a surgical provider who is willing to perform the procedure; for patients who will have their tumor sample obtained in the operating room, the surgeon must document that they believe the procedure to be medically appropriate
- No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of starting IFN gamma
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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