NCT00019994已完成2 期
Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens
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.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
详细描述
OBJECTIVES:
- Determine the clinical response to immunization using gp100:44-59 antigen peptide plus gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with metastatic melanoma who are HLA-DRB1*0401 and HLA-A0201 positive.
- Determine the clinical response to immunization using gp100:44-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB1*0401 positive but HLA-A0201 negative.
- Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment.
- Evaluate the toxicity profiles of these regimens in these patients.
OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100:209-217 (210M) antigen peptide immunization:
- Group 1 (HLA-A0201 positive and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC.
- Group 2 (HLA-A0201 positive and prior gp100:209-217 [210M] antigen peptide): Patients receive treatment as in group 1.
- Group 3 (HLA-A0201 negative and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone.
- All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients with complete response after 4 doses receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed, or partial response after 4 doses receive a maximum of 12 additional doses. Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization.
Patients are followed at 3-4 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 metastatic melanoma that has failed standard treatment
- •HLA-DRB1*0401 positive
- •Known HLA-A0201 status
- •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
- •AST or ALT 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 autoimmune disease
- •No primary or secondary immunodeficiency disease
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active systemic infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunization to the entire gp100 molecule
- •At least 3 weeks since prior gp100:209-217 antigen peptide
- •At least 3 weeks since other prior biologic therapy
- •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 for cancer allowed
- •At least 3 weeks since any prior therapy except surgery for cancer
排除标准
- 未提供
研究者
研究点 (1)
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