NCT00072085已完成2 期
Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 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: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without gp100:209-217 (210M) peptide.
Secondary
- Compare the toxicity profile of these immunizations in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •Measurable disease
- •Progressive disease during or after prior standard treatment with or without interleukin-2
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Platelet count at least 90,000/mm^3
- •Lymphocyte count greater than 500/mm^3
- •Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
- •ALT and AST less than 3 times normal
- •Hepatitis B surface antigen negative
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No symptomatic cardiac disease
- •Immunologic
- •No active systemic infection
- •No autoimmune disease
- •No known immunodeficiency disease
- •No known hypersensitivity to study agents
- •No form of primary or secondary immunodeficiency
- •No opportunistic infection
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •No prior gp100 peptide vaccine
- •Chemotherapy
- •More than 6 weeks since prior nitrosoureas
- •Endocrine therapy
- •No concurrent systemic steroid therapy
- •Radiotherapy
- •Not specified
- •Prior recent (within the past 3 weeks) minor surgical procedures allowed
- •Recovered from prior therapy (toxicity no greater than grade 1)
- •More than 3 weeks since prior systemic anticancer therapy
- •No other concurrent systemic anticancer therapy
排除标准
- 未提供
研究者
研究点 (2)
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