NCT00104780Unknown2 期
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)
Epimmune18 个研究点 分布在 1 个国家开始时间: 2004年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 18
- 主要终点
- Safety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 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 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:
- •18 and over
- •Performance status
- •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
- •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
- •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
- •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
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety
Comparison of overall survival with historical controls
次要结局
- Progression-free survival
- Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
研究者
研究点 (18)
Loading locations...
相似试验
已完成
2 期
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous LeukemiaLeukemiaNCT00466726Gruppo Italiano Malattie EMatologiche dell'Adulto57
Unknown
3 期
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in RemissionLeukemiaNCT00454168The Vaccine Company244
终止
2 期
Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous LeukemiaLeukemiaNCT00428077OHSU Knight Cancer Institute4
已完成
2 期
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma MultiformeMalignant Neoplasms of BrainNCT00643097John Sampson40
终止
2 期
Vaccine Therapy, Paclitaxel, and Carboplatin in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00373217Craig L Slingluff, Jr6