Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine (limited to the specific K-ras peptide mutation in their tumors) and sargramostim (GM-CSF).
- Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive sargramostim (GM-CSF) intradermally (ID) on days 1-10 beginning a maximum of 6 months after complete surgical resection. Patients receive mutant K-ras peptide vaccine (limited to the specific K-ras mutation in their tumors) ID on day 7. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 and 12 weeks.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 18 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven stage IB-IV non-small cell lung cancer
- •Non-squamous cell histology only
- •Must have undergone curative surgery within the past 6 months and must be free of recurrence
- •Tumor must demonstrate a specific K-ras mutation at codon 12 for which a vaccine preparation is available
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Not specified
- •Not specified
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No concurrent medical condition that would preclude compliance or immunologic response to study treatment
- •No other serious concurrent medical condition
- •No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the uterine cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 3 weeks since prior postoperative chemotherapy and recovered
- •Endocrine therapy:
- •No concurrent systemic steroids
- •Concurrent inhaled steroids allowed
- •Radiotherapy:
- •No prior radiotherapy to spleen
- •At least 3 weeks since prior postoperative radiotherapy and recovered
- •See Disease Characteristics
- •No prior splenectomy
- •No concurrent immunosuppressive drugs or antiinflammatory drugs
排除标准
- 未提供