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
- 2
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
- 未提供
排除标准
- 未提供
研究者
研究点 (2)
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