Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma (2705)
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
|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.
Eligibility Criteria (must meet the following to participate in this study)
- 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
Exclusions (conditions that would prevent participation in this study)
- 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
Last UpdatedOctober 25, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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