A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma To The Lung
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 24
- 主要终点
- Determine the 4-month progression-free survival rate
研究概览
简要总结
RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may be an effective treatment for patients with kidney cancer that has spread to the lung.
PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung.
详细描述
OBJECTIVES:
- Determine the 4-month progression-free survival rate and overall survival rate in patients with metastatic renal cell carcinoma to the lung treated with aerosolized sargramostim (GM-CSF).
- Determine the toxicity of this regimen in these patients.
- Determine the immunomodulatory effects of this regimen in terms of natural killer cells cytotoxicity, and T-cell, B-cell, and dendritic cell activation markers.
OUTLINE: This is a multicenter study.
Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21. Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity.
Patients are followed for disease progression and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic renal cell carcinoma for which no known standard therapy that is potentially curative or capable of extending life expectancy exists (e.g., surgery)
- •Measurable metastatic disease in the lung
- •At least one unidimensionally measurable lesion at least 20 mm by conventional techniques
- •No CNS metastases that require treatment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 75,000/mm^3
- •Hemoglobin greater than 8.0 g/dL
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST no greater than 3 times ULN
- •Creatinine no greater than 2.5 times ULN
- •No hemoptysis of grade 3 or greater
- •No reactive airway disease on active therapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled infection
- •No other metastatic malignancy within the past 3 years except basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 2 weeks since prior immunotherapy
- •More than 2 weeks since other prior biologic therapy
- •Chemotherapy
- •More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
- •Endocrine therapy
- •More than 2 weeks since prior corticosteroids
- •No concurrent systemic glucocorticoids
- •Radiotherapy
- •More than 2 weeks since prior radiotherapy
- •No prior radiotherapy to more than 10% of total lung volume in the radiation field
- •At least 4 weeks since prior bronchodialators
- •No concurrent immunosuppressive agents
排除标准
- 未提供
研究组 & 干预措施
aerosolized sargramostim
Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21. Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity.
Patients are followed for disease progression and then every 3 months thereafter.
干预措施: sargramostim (Biological)
结局指标
主要结局
Determine the 4-month progression-free survival rate
时间窗: 4 months
次要结局
- Determine the 4-month overall survival rate(4 months)