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临床试验/NCT00019383
NCT00019383已完成2 期

Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)

National Cancer Institute (NCI)2 个研究点 分布在 1 个国家开始时间: 1998年1月最近更新:
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. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma.

详细描述

OBJECTIVES:

  • Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen, either alone or when combined with 1 of 3 adjuvants.
  • Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients.

OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31).

Patients are assigned to 1 of 4 vaccine groups:

  • Group 1 (HLA-A1 positive): Patients receive tyrosinase:240-251.
  • Group 2 (HLA-A3 positive): Patients receive gp100:17-25. (closed to accrual 5/17/2000)
  • Group 3 (HLA-A24 positive): Patients receive tyrosinase:206-214.
  • Group 4 (HLA-A31 positive): Patients receive tyrosinase related protein-1. Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF) SQ) depending on the time of entry into study and response to treatment.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (2)

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