Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
2013年11月5日 更新者：Epimmune
A Phase II, Open Label, Multi-center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
研究概览
详细说明
OBJECTIVES:
Primary
- Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only.
- Determine the safety of this vaccine in these patients.
Secondary
- Determine progression-free survival of patients treated with this vaccine.
- Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine.
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status.
- Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15.
- Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
研究类型
介入性
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Florida
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Ocoee、Florida、美国、34761
- Cancer Centers of Florida - Ocoee
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New York
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Albany、New York、美国、12208
- New York Oncology Hematology, P. C. at Albany Regional Cancer Care
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North Carolina
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Ohio
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Kettering、Ohio、美国、45409
- Dayton Oncology & Hematology, P.A. - Kettering
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South Carolina
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Greenville、South Carolina、美国、29615
- Cancer Centers of the Carolinas - Eastside
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Tennessee
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Nashville、Tennessee、美国、37203
- Sarah Cannon Cancer Center at Centennial Medical Center
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Texas
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Dallas、Texas、美国、75246
- Mary Crowley Medical Research Center at Sammons Cancer Center
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Tyler、Texas、美国、75702
- Tyler Cancer Center
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Washington
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Spokane、Washington、美国、99218
- Cancer Care Northwest - North
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:
- Stage IIIB disease
- Stage IV disease
- Recurrent disease
HLA-A2-positive disease
- HLA-A2 negative patients are eligible to enroll in group II (observation) only
- Measurable disease
- Estimated tumor volume ≤ 125 cc
No CNS signs or symptoms of brain metastases
- Brain metastases that are clinically stable for ≥ 2 months AND do not require anticonvulsants or systemic steroids are allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 12 weeks
Hematopoietic
- Hemoglobin ≥ 10 g/dL
- Platelet count > 100,000/mm^3
- WBC > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Absolute lymphocyte count > 500/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver involvement by tumor)
- Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL for patients with liver involvement by tumor)
- Albumin ≥ 2.5 g/dL
- Alkaline phosphatase ≤ 2.5 times ULN
- No history of hepatitis B or C positivity
Renal
- Creatinine ≤ 2 times ULN
Immunologic
No history of any of the following active conditions:
- Systemic lupus erythematosus
- Scleroderma
- Connective tissue disease
- Sjögren's syndrome
- Multiple sclerosis
- Rheumatoid arthritis
- Inflammatory bowel disease
- No history of HIV positivity
- No history of serious adverse reaction, including anaphylaxis, or hypersensitivity to study vaccine or to any of its components
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 weeks after completion of study treatment
- No other malignancy within the past 5 years except curatively excised nonmelanoma skin cancer or surgically cured carcinoma in situ of the cervix
- No other acute medical condition that would preclude study treatment
- No mental or psychiatric condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 1 month since prior interferon therapy
- More than 1 month since prior interleukin therapy
- No prior cancer vaccine therapy, including participation in a vaccine study
Chemotherapy
- At least 4 weeks since prior chemotherapy
Endocrine therapy
- See Disease Characteristics
- More than 1 month since prior systemic corticosteroids except stable doses of inhaled corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- No concurrent participation in another investigational study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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安全
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Comparison of overall survival with historical controls
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次要结果测量
结果测量 |
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无进展生存期
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Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 学习椅：Scott Plasman、Epimmune
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年12月1日
研究注册日期
首次提交
2005年3月3日
首先提交符合 QC 标准的
2005年3月3日
首次发布 (估计)
2005年3月4日
研究记录更新
最后更新发布 (估计)
2013年11月6日
上次提交的符合 QC 标准的更新
2013年11月5日
最后验证
2006年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
肺癌的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利
不完全弗氏佐剂的临床试验
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National Institute of Allergy and Infectious Diseases...招聘中