NCT00020397已完成2 期
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.
详细描述
OBJECTIVES:
- Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04 positive patients with refractory metastatic melanoma expressing ESO-1.
- Determine the toxicity of this vaccine in these patients.
- Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2.
OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type.
- Group 1 (HLA-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only.
- Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only.
Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 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:
- •Diagnosis of metastatic melanoma that expresses ESO-1 antigen
- •Must have progressed during prior standard treatment
- •Measurable or evaluable disease
- •HLA-A*201 or HLA-DPB1*04 positive
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 90,000/mm^3
- •SGOT and SGPT less than 3 times normal
- •Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
- •Hepatitis B surface antigen negative
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No cardiac ischemia*
- •No myocardial infarction*
- •No cardiac arrhythmias* NOTE: *For interleukin-2 (IL-2) administration
- •No obstructive or restrictive pulmonary disease (for IL-2 administration)
- •Immunologic:
- •No autoimmune disease
- •No active primary or secondary immunodeficiency
- •HIV negative
- •No active systemic infections
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other active major medical illness (for IL-2 administration)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior ESO-1 immunization
- •Chemotherapy:
- •Recovered from any prior chemotherapy
- •Endocrine therapy:
- •No concurrent systemic steroid therapy
- •Radiotherapy:
- •Recovered from any prior radiotherapy
- •Not specified
- •At least 3 weeks since any prior systemic therapy for cancer
- •No other concurrent systemic therapy for cancer
排除标准
- 未提供
研究者
研究点 (2)
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