Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
研究概览
简要总结
RATIONALE: Vaccines made from a person's cancer 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 stage IV or recurrent melanoma.
详细描述
OBJECTIVES:
- Determine the safety of immunization with autologous in vitro-treated tumor cells and dendritic cells in combination with sargramostim (GM-CSF) in patients with stage IV or recurrent melanoma.
- Determine the frequency of conversion of delayed tumor hypersensitivity tests in patients treated with this regimen.
- Determine the progression-free and overall survival in patients treated with this regimen.
- Determine the objective tumor response rate in patients with measurable melanoma treated with this regimen.
OUTLINE: Patients are stratified according to presence of measurable disease at study initiation (yes vs no).
Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease after harvest may receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion over approximately 4 months. The tumor cell line is expanded, irradiated, and treated with interferon gamma.
Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC) to obtain dendritic cells (DC). The PBMC are treated with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce DC. The DC are then cultured with the treated tumor cells for 18 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 stage IV or recurrent melanoma
- •Metastatic disease confirmed by MRI or CT scan
- •Planned resection of tumor
- •No active CNS metastases
- •Radiographically confirmed lack of CNS disease progression
- •No requirement for pharmacologic doses of corticosteroids
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •Hematocrit greater than 25%
- •Platelet count greater than 100,000/mm^3
- •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
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No underlying cardiac disease associated with known myocardial dysfunction
- •No unstable angina related to atherosclerotic cardiovascular disease
- •No other malignancy within the past 5 years except for carcinoma in situ, basal cell carcinoma, or localized squamous cell skin cancer
- •No active, eminently life-threatening infection or medical condition
- •Adequate venous access
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Other prior putative vaccines allowed
- •Recovered from prior biologic therapy
- •No other 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 endocrine therapy
- •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 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: therapeutic autologous dendritic cells (Biological)
结局指标
主要结局
To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
时间窗: treatment
To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF
时间窗: treatment
次要结局
- To determine the objective tumor response rate in patients with metastatic melanoma who still had measurable disease at the time vaccine treatment was given(follow-up)