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)
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. 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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven refractory metastatic melanoma
- •Must be HLA-A1, HLA-A3, HLA-A24, or HLA-A31 positive
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance Status:
- •Life Expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 90,000/mm^3
- •No coagulation disorder
- •AST or ALT less than 2 times upper limit of normal
- •Bilirubin no greater than 1.6 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No major cardiovascular disease
- •No major respiratory disease
- •Not pregnant
- •Fertile patients must use effective contraception
- •HIV negative
- •Hepatitis B surface antigen negative
- •No known allergy to Montanide ISA-51
- •No active systemic infection
- •No immunodeficiency disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic therapy
- •No concurrent biologic therapy
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy:
- •At least 3 weeks since prior endocrine therapy
- •No concurrent steroid therapy or other endocrine therapy
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •Prior or concurrent surgery for melanoma allowed
排除标准
- 未提供
研究者
研究点 (1)
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