Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
RATIONALE: Colony-stimulating factors, such as sargramostim, may help the body's immune system to kill cancer cells. Giving sargramostim in different ways may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim given as a breathing treatment for treating patients who have melanoma that is metastatic to the lung.
研究概览
详细说明
OBJECTIVES: I. Determine the therapeutic effects of aerosolized sargramostim (GM-CSF) in terms of progression free survival at 2 months and median survival rate in patients with metastatic melanoma to the lung. II. Determine the immunomodulatory effects of this treatment regimen in this patient population. III. Assess the quality of life in terms of physical and personal concerns of these patients treated with this regimen.
OUTLINE: Patients receive aerosolized sargramostim (GM-CSF) over 10-15 minutes twice daily for 7 days. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to course 5. Patients are followed every 2 months for at least 1.5 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Arizona
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Scottsdale、Arizona、美国、85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville、Florida、美国、32224
- Mayo Clinic Jacksonville
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Illinois
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Peoria、Illinois、美国、61602
- Illinois Oncology Research Association
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Urbana、Illinois、美国、61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids、Iowa、美国、52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines、Iowa、美国、50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City、Iowa、美国、51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita、Kansas、美国、67214-3882
- CCOP - Wichita
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Minnesota
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Duluth、Minnesota、美国、55805
- CCOP - Duluth
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Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
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Saint Cloud、Minnesota、美国、56303
- CentraCare Clinic
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Saint Louis Park、Minnesota、美国、55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha、Nebraska、美国、68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Fargo、North Dakota、美国、58122
- CCOP - Merit Care Hospital
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Ohio
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Toledo、Ohio、美国、43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Pennsylvania
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Danville、Pennsylvania、美国、17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City、South Dakota、美国、57709
- Rapid City Regional Hospital
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Sioux Falls、South Dakota、美国、57105-1080
- CCOP - Sioux Community Cancer Consortium
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically confirmed melanoma with radiographic evidence of prior or active involvement of the lung or pleura Measurable disease At least one lesion with at least one dimension in diameter of at least 10 mm on CT scan or MRI No non-measurable disease including the following: Bone lesions Leptomeningeal disease Ascites Pleural or pericardial effusion Inflammatory breast disease Lymphangitis cutis or pulmonis Unconfirmed abdominal masses not followed by imaging Cystic lesions
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic or immunotherapy No other concurrent biologic or immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior corticosteroids No concurrent systemic glucocorticosteroids Radiotherapy: At least 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: No concurrent immunosuppressants
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:sargramostim
Patients receive aerosolized sargramostim (GM-CSF) over 10-15 minutes twice daily for 7 days. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to course 5. Patients are followed every 2 months for at least 1.5 years. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Progression-free survival
大体时间:2 months
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2 months
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Median survival
大体时间:Up to 1.5 years
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Up to 1.5 years
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次要结果测量
结果测量 |
大体时间 |
---|---|
Quality of life
大体时间:Up to 1.5 years
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Up to 1.5 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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