Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients
RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes.
研究概览
地位
条件
干预/治疗
- 程序:辅助治疗
- 其他:流式细胞仪
- 生物:HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine
- 生物:HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine
- 生物:autologous melanoma lysate-pulsed autologous dendritic cell vaccine
- 生物:autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine
- 生物:dendritic cell-idiotype-keyhole limpet hemocyanin vaccine
详细说明
OBJECTIVES:
- Determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic cells pulsed with tumor antigen peptides in patients with stage III melanoma following lymphadenectomy.
- Determine the immune response (skin test of delayed-type hypersensitivity and flow cytometric enumeration of peripheral blood CD8+ lymphocytes producing IFN-γ) to this regimen in these patients.
- Determine clinical outcome (disease-free survival, overall survival, and adverse events) in patients treated with this regimen.
OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs) and bone marrow mononuclear cells. Autologous dendritic cells (DCs) prepared from PBMCs and bone marrow mononuclear cells are exposed to various antigens and peptides, and autologous tumor cell lysate, if available. Patients receive autologous DCs pulsed with melanoma-associated antigen peptides, and autologous DCs pulsed with tumor lysates (if available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. Patients with no evidence of disease may receive another booster injection 5 years after the start of vaccination.
Blood samples are examined via flow cytometry and skin testing is performed to evaluate immune response.
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Warsaw、波兰、02-781
- 招聘中
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
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接触:
- Contact Person
- 电话号码:48-22-546-2660
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Diagnosis of stage III melanoma
- Has undergone therapeutic lymphadenectomy
- More than 1 lymph node involvement or extracapsular extension of metastatic melanoma cells (stage N1b-N3 disease according to AJCC 2002)
- HLA type A1 and/or A2 or A3 (if autologous tumor lysate is available)
- No presence of distant metastases
PATIENT CHARACTERISTICS:
- No other malignancy
- No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
- No autoimmune disease or atopic allergy
- No HIV infection or presence of anti-HIV antibodies
- No presence of hepatitis B surface antigen or antibodies against hepatitis C virus
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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不良事件
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总生存期
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无病生存
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免疫反应
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合作者和调查者
调查人员
- 首席研究员:Sergiusz Markowicz, MD、Maria Sklodowska-Curie National Research Institute of Oncology
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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