NCT00019721已完成2 期
Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.
PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.
详细描述
OBJECTIVES:
- Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.
- Determine the efficacy of these peptides in patients who cannot receive IL-2.
- Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.
- Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.
- Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a partially randomized study.
Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.
- Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 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:
- •Histologically confirmed metastatic melanoma that has failed standard therapy
- •Measurable disease
- •HLA-A0201 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
- •Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
- •AST/ALT less than 3 times normal
- •Hepatitis B surface antigen negative
- •No coagulation disorder
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No major cardiovascular disease
- •If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only
- •No major respiratory disease
- •Not pregnant
- •Fertile patients must use effective contraception
- •HIV negative
- •No active systemic infection
- •No autoimmune disease or immunodeficiency disease
- •No primary or secondary immunodeficiency
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic therapy
- •No prior MART-1 antigen immunization
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy
- •Endocrine therapy:
- •At least 3 weeks since prior endocrine therapy
- •No concurrent steroid therapy
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy
- •Prior surgery allowed
排除标准
- 未提供
研究者
研究点 (1)
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