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
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma
时间窗: Baseline to up to 2 weeks post-surgery
It would be highly relevant to observe marked increase macrophages (effect size \> 2.5). Four patients gives over 90% power to detect such a large increase with a two-tailed alpha of 0.05.
次要结局
- Changes in Immune Response(Baseline to 2 weeks post biopsy)
- MHC Class II Expression(Baseline to 2 weeks post biopsy.)