NCT00357461撤回2 期
A Randomized Phase II Study of Fixed Dose Ipilimumab (MDX-010) 10 mg/kg Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 VG for Previously Treated HLA-A * 0201 Positive Subjects With Stage IV Melanoma
Bristol-Myers Squibb0 个研究点开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Clinical response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma.
PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Compare the impact of ipilimumab with vs without gp100 peptides emulsified with Montanide ISA-51 on clinical response in patients with previously treated, HLA-A*0201 positive stage IV melanoma.
Secondary
- Compare the safety/toxicity profile of these regimens in these patients.
- Determine the immunologic response, as measured by in vitro assays using peripheral blood samples, in patients treated with these regimens.
- Determine the response rate after a re-induction regimen for patients who have relapsed after initial response.
- Determine overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •HLA-A*0201 positive disease
- •Previously treated metastatic disease
- •Clinically evaluable and measurable disease
- •No mucosal or ocular melanoma
- •No evidence of active brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •WBC ≥ 2,500/mm³
- •Absolute neutrophil count ≥ 1,000/mm³
- •Absolute lymphocyte count ≥ 500/mm³
- •Platelet count ≥ 75,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Creatinine < 2.5 mg/dL
- •AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Bilirubin normal (< 3.0 mg/dL if Gilbert's syndrome is present)
- •Hepatitis B surface antigen negative
- •HIV negativity
- •No hepatitis C virus antibodies
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other prior malignancy except for any of the following:
- •Adequately treated basal cell or squamous cell skin cancer
- •Superficial bladder cancer
- •Carcinoma in situ of the cervix
- •Any other cancer from which patient has been disease free for > 5 years
- •No active immune-mediated disease requiring active therapy with any form of steroid or immunosuppressive therapy
- •No documented history of any of the following:
- •Inflammatory bowel disease
- •Regional enteritis
- •Connective tissue disorders, such as systemic lupus erythematosus
- •Rheumatoid arthritis
- •Immune-mediated inflammatory eye disease
- •Sjögren's syndrome
- •Inflammatory neurologic disorder, such as multiple sclerosis
- •Any immune-mediated disease that can cause life-threatening symptoms or severe organ/tissue damage, in the opinion of the principal investigator
- •History of vitiligo or immune-mediated thyroiditis allowed
- •Skin rashes associated with previous therapy allowed provided patient has recovered from treatment-related toxicity to < grade 1
- •No active infection
- •No systemic hypersensitivity to any of the study drugs
- •History of local reactions (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 allowed
- •No underlying medical condition that, in the opinion of the investigator, would preclude study treatment
- •PRIOR CONCURRENT THERAPY:
- •At least 3 weeks since prior systemic treatment (6 weeks for nitrosoureas) and recovered
- •No prior ipilimumab or gp100 vaccines
- •More than 4 weeks since prior steroids
- •No concurrent systemic or topical corticosteroids or immunosuppressive agents (e.g., cyclosporine or chemotherapy agents), including steroid enemas, inhaled steroids, or steroid eye drops
- •Hormone-replacement therapy allowed
排除标准
- 未提供
结局指标
主要结局
Clinical response
次要结局
- Safety and toxicity
- Immunologic response
- Response rate
- Overall survival
研究者
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