NCT00077532已完成2 期
A Study of Intra-Patient Escalating Doses of MDX-010 Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 in the Treatment of Patients With Stage IV Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Objective response (partial and complete)
研究概览
简要总结
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma.
PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the clinical response in patients with stage IV melanoma treated with escalating doses of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) with or without gp100 peptides emulsified in Montanide ISA-51.
Secondary
- Determine the safety and toxicity profile of these regimens in these patients.
- Determine the immunologic response in patients treated with these regimens.
- Determine the pharmacokinetics of these regimens in these patients.
- Determine, in HLA-A*0201-positive patients, the differences in responses between patients previously vaccinated with gp100 peptides and patients not previously vaccinated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 confirmed stage IV melanoma
- •Clinically evaluable or measurable disease
- •No mucosal or ocular melanoma
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Hematocrit ≥ 28%
- •WBC ≥ 2,500/mm^3
- •AST ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ ULN (< 3 mg/dL for patients with Gilbert's syndrome)
- •Hepatitis B surface antigen negative
- •Hepatitis C virus antibody negative
- •Creatinine < 2 mg/dL
- •Immunologic
- •HIV negative
- •No history of any of the following:
- •Inflammatory bowel disease
- •Regional enteritis
- •Connective tissue disorders (e.g., systemic lupus erythematosus)
- •Rheumatoid arthritis
- •Autoimmune inflammatory eye disease
- •Sjögren's syndrome
- •Inflammatory neurologic disorder (e.g., multiple sclerosis)
- •No active infection
- •No active autoimmune disease that may cause life-threatening symptoms or severe organ/tissue damage
- •Vitiligo, autoimmune thyroiditis, or skin rashes associated with prior therapy are allowed if patient has recovered to grade 1 or less toxicity
- •No systemic hypersensitivity to study agents
- •Prior local reaction (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 or gp100 injections allowed
- •No autoimmune disease requiring active therapy with any form of steroid or immunosuppressant
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent underlying medical condition that would preclude study participation
- •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
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
- •Prior therapy with gp100 peptides or any other immunotherapy allowed
- •Chemotherapy
- •At least 6 weeks since prior nitrosoureas and recovered (toxicity no greater than grade 1)
- •No concurrent chemotherapy
- •Endocrine therapy
- •At least 4 weeks since prior steroids
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective response (partial and complete)
次要结局
- Safety
- Immune response activity
研究者
研究点 (1)
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