Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I
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 made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer.
- Determine the immunologic response in patients treated with this vaccine.
OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart.
Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer
- •Tumor diameter of at least 3 cm
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •AST less than 2 times upper limit of normal (ULN)
- •Lactate dehydrogenase less than 2 times ULN
- •Hepatitis B and C negative
- •Creatinine no greater than 1.4 mg/dL
- •Positive cell mediated immunity test (i.e., greater than 5 mm induration in 48 hours with purified protein derivative (of tuberculin), candida, and mumps intradermal injection skin test)
- •HIV negative
- •No active systemic infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biological materials
- •Chemotherapy:
- •At least 4 weeks since prior cytotoxic or chemotherapeutic agents
- •Concurrent chemotherapy allowed after surgery and before vaccination
- •Endocrine therapy:
- •No concurrent steroid therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •Concurrent radiotherapy allowed after surgery and before vaccination
- •See Disease Characteristics
排除标准
- 未提供