NCT00112580已完成2 期
Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2005年7月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with stage IV pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine clinical response (partial and complete responses) in patients with unresectable stage IV (locally or distantly metastatic) pancreatic adenocarcinoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010).
Secondary
- Determine whether observed responses correlate with the incidence of autoimmunity in patients treated with this drug.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed pancreatic adenocarcinoma
- •Stage IV disease
- •Locally (invasion of adjacent structures, including mesenteric arteries or organs) or distantly metastatic disease
- •Unresectable disease
- •Pancreatic adenocarcinoma with intraductal papillary mucinous neoplasm allowed
- •The following diagnoses are not allowed:
- •Acinar cell carcinoma
- •Pancreaticoblastoma
- •Malignant cystic neoplasms
- •Endocrine neoplasms
- •Squamous cell carcinoma
- •Vater and periampullary duodenal or common bile duct malignancies
- •Clinically evaluable disease with ≥ 1 site of measurable disease
- •Biliary or gastric outlet obstruction allowed provided it is effectively drained by endoscopic, operative, or interventional means
- •Pancreatic, biliary, or enteric fistulae allowed provided they are controlled with an appropriate drain
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •WBC ≥ 2,500/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Hematocrit ≥ 27%
- •Hepatitis B surface antigen negative
- •Hepatitis C virus antibody negative OR
- •Hepatitis C RNA negative by polymerase chain reaction
- •Creatinine < 2.0 mg/dL
- •Immunologic
- •HIV negative
- •No history of or active autoimmune disease, including uveitis or autoimmune inflammatory eye disease
- •No active uncontrolled infection
- •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 underlying medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy for pancreatic adenocarcinoma and recovered
- •No concurrent chemotherapy
- •Endocrine therapy
- •More than 4 weeks since prior corticosteroids
- •No concurrent systemic or topical corticosteroids
- •Radiotherapy
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
时间窗: From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks.
Percentage of participants who achieved Complete Response (CR) or Partial Response (PR) according to RECIST criteria. Particularly, CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease n the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
次要结局
未报告次要终点
研究者
研究点 (2)
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