NCT00074230已完成1 期
Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3, MelanA, and Survivin Antigens
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Safety and tolerability at every visit
研究概览
简要总结
RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin antigens in patients with stage IV cutaneous melanoma.
- Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine.
- Determine whether simultaneous loading of DC with keyhole limpet hemocyanin (KLH) significantly enhances induction of the Melan-A, MAGE-3, and survivin antigens in these patients.
Secondary
- Determine clinical antitumor activity (e.g., objective tumor response, time to tumor progression, progression-free interval, and overall survival) in patients treated with this vaccine.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cutaneous* melanoma
- •Incurable by surgical resection
- •Progressive disease after at least 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy)
- •Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or noninvasive radiological procedures
- •No active CNS metastases by CT scan or MRI
- •Previously treated (e.g., excision of a single metastasis) CNS metastases are allowed provided there are no signs of active CNS metastases NOTE: *Metastatic melanoma with unidentified primary tumor allowed provided an ocular melanoma can be definitely excluded and origin from the skin is likely
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •At least 4 months
- •Hematopoietic
- •WBC greater than 2,500/mm^3
- •Neutrophil count greater than 1,000/mm^3
- •Lymphocyte count greater than 700/mm^3
- •Platelet count greater than 75,000/mm^3
- •Hemoglobin greater than 9 g/dL
- •No bleeding disorder
- •Bilirubin less than 2.0 mg/dL
- •No evidence of hepatitis B or C infection
- •Creatinine less than 2.5 mg/dL
- •Cardiovascular
- •No clinically significant heart disease
- •No respiratory disease
- •Immunologic
- •HIV-1 and HIV-2 negative
- •HTLV-1 negative
- •No active systemic infection
- •No immunodeficiency disease
- •No active autoimmune disease (e.g., lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, or inflammatory bowel disease)
- •Vitiligo allowed
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 4 weeks after study participation
- •Stable medical condition
- •No other major serious illness
- •No contraindication to leukapheresis
- •No organic brain syndrome or significant psychiatric abnormality that would preclude study participation or follow-up
- •No other active malignant neoplasm
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy
- •No other concurrent immunotherapy during and for 2 weeks after study participation
- •Chemotherapy
- •More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas [e.g., fotemustine])
- •No concurrent chemotherapy during and for 2 weeks after study participation
- •Endocrine therapy
- •No concurrent corticosteroids during and for 2 weeks after study participation
- 另有 12 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability at every visit
时间窗: 3 months
Overall survival as assessed by clinical staging (CT scan, positron emission tomography [PET]) every 3 months
时间窗: 3 months
次要结局
- Time to progression as assessed by clinical staging (CT scan, PET) every 3 months(3 months)
- Duration of response as assessed by clinical staging (CT scan, PET) every 3 months(3 months)
- Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit(3 months)
- Objective tumor response as assessed by clinical staging (CT scan, PET) every 3 months(3 months)
研究者
PD Dr. med. univ. Beatrice Schuler-Thurner
Principal Investigator
University Hospital Erlangen
研究点 (1)
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