An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma
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 made from peptides may make the body build an immune response to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51.
- Determine a safety and adverse event profile of this regimen in these patients.
- Determine improved immunologic response in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
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 confirmed stage IV melanoma
- •Mucosal or ocular melanoma allowed
- •Clinically evaluable disease
- •HLA-A*0201 positive
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •WBC at least 2,500/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Hematocrit at least 30%
- •AST no greater than 3 times upper limit of normal (ULN)
- •Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome)
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody nonreactive
- •Creatinine less than 2.0 mg/dL
- •Immunologic:
- •Antinuclear antibody negative
- •Thyroglobulin antibody normal
- •Rheumatoid factor normal
- •HIV negative
- •No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
- •No active infection
- •No hypersensitivity to Montanide ISA-51
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- •No other underlying medical condition that would preclude study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior immunotherapy for melanoma and recovered
- •No prior gp100 peptides
- •No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy for melanoma and recovered
- •No concurrent chemotherapy
- •Endocrine therapy:
- •At least 3 weeks since prior hormonal therapy for melanoma and recovered
- •At least 4 weeks since prior systemic or topical corticosteroids
- •No concurrent topical or systemic corticosteroids
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy for melanoma and recovered
- •Not specified
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排除标准
- 未提供