Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
研究概览
简要总结
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer.
详细描述
OBJECTIVES:
- Determine the safety of immunization with in vitro-treated autologous tumor cells and dendritic cells with sargramostim (GM-CSF) in patients with stage III or IV or recurrent renal cell cancer.
- Determine the frequency of conversion of delayed tumor hypersensitivity tests in these patients treated with this regimen.
- Determine the progression-free and overall survival of these patients treated with this regimen.
- Determine the objective tumor response rate in patients who still have measurable disease at the time they are treated with this regimen.
OUTLINE: Patients are stratified according to measurable disease at the time vaccine therapy is initiated (yes vs no).
Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease following harvest receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion. Over 2-4 months, the tumor cell line is expanded, treated with interferon gamma, and irradiated.
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). The PBMC are incubated over 7 days with sargramostim (GM-CSF) and interleukin-4 to produce dendritic cells (DC). The DC are incubated over 2-3 days with the irradiated tumor cells from the autologous tumor cell line for antigen loading of the DC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed renal cell carcinoma
- •Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR
- •Recurrent disease involving lymph node metastases or soft tissue nodules
- •Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery)
- •Planned resection of tumor to establish an autologous tumor cell line
- •No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease
- •Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •Hematocrit greater than 25%
- •Platelet count greater than 100,000/mm3
- •No ongoing transfusion requirements
- •No active blood clotting or bleeding diathesis
- •Bilirubin no greater than 2.0 mg/dL
- •Albumin at least 3.0 g/dL
- •No significant hepatic dysfunction
- •Creatinine no greater than 2.0 mg/dL
- •No significant renal dysfunction
- •Cardiovascular:
- •No underlying cardiac disease associated with New York Heart Association class III or IV heart function
- •No unstable angina related to atherosclerotic cardiovascular disease
- •No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer
- •No active infection
- •No other active medical condition that could be eminently life threatening
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Other prior putative vaccines allowed
- •Recovered from prior biologic therapy
- •No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36%
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy and recovered
- •No concurrent chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •No concurrent corticosteroids
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered
- •No concurrent radiotherapy
- •See Disease Characteristics
- •Recovered from prior surgery
- •Concurrent bisphosphonates allowed for patients with lytic bone metastases
- •No concurrent digoxin or other medications designed to improve cardiac output
- •No other concurrent anticancer therapy or investigational therapy
排除标准
- 未提供
研究组 & 干预措施
Biological/Vaccine
Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
干预措施: Biological/Vaccine: therapeutic autologous dendritic cells. (Biological)
结局指标
主要结局
Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
时间窗: week 4 and month 6 during vaccine therapy
Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
时间窗: months 2 or 3 and 6 during study treatment and every 6 months after study completion
Overall survival beginning at the date of study entry
时间窗: 5 years or until death, whichever came first.
Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion
时间窗: months 2 or 3 and 6 during study treatment, and 6 months after study completion
Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
时间窗: months 2 or 3 and 6 during study treatment and every 6 months after study completion
次要结局
未报告次要终点