NCT00047164已完成1 期
A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with follicular or mantle cell lymphoma, colon cancer, or prostate cancer refractory to vaccine therapy. (part I) (prostate cancer and mantle cell lymphoma closed to accrual as of 3/10/2005; colon cancer closed to accrual as of 9/28/05)
- Determine the toxicity of this drug at escalating doses in patients with follicular lymphoma. (part II)
- Determine the toxicity of this drug at escalating doses in patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma. (part III)
Secondary
- Determine the ability of this drug to increase tumor-specific T-cell responses in these patients.
- Determine the ability of this drug to produce clinical tumor response in these patients.
- Determine the effect of this drug on suppressor T-cell populations (CD4+ and CD25+ cells) in these patients.
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 prostate cancer (closed to accrual as of 3/9/2005)
- •Prior therapy on protocol NCI-00-C-0137 or NCI-00-C-0154
- •Progressive disease (2 consecutively rising PSA levels, new bone scan lesion, or progression of soft tissue)
- •PSA at least 5 ng/mL
- •Progressive androgen-independent disease
- •Disease progression at least 4 weeks after flutamide withdrawal OR
- •Disease progression at least 6 weeks after bicalutamide or nilutamide withdrawal OR
- •Histologically confirmed follicular or mantle cell non-Hodgkin's lymphoma (mantle cell lymphoma closed to accrual as of 3/9/2005)
- •Prior therapy on protocol NCI-00-C-0133, NCI-01-C-0169, or NCI-00-C-0050
- •Progressive disease after standard treatment
- •Relapsed disease OR
- •Histologically confirmed colon cancer (colon cancer closed to accrual as of 9/28/05)
- •Prior therapy on protocol NCI-99-C-0023
- •Progressive disease OR
- •Histologically confirmed non-Hodgkin's lymphoma or Hodgkin's lymphoma
- •Progressive disease after standard treatment
- •No curative therapy exists
- •Prior allogeneic stem cell transplantation from a matched sibling or matched unrelated donor for an aggressive lymphoma allowed
- •Last infusion of allogeneic cells (either hematopoietic stem cells or donor lymphocytes) must have occurred > 90 days prior to study enrollment
- •No other standard therapy available or refused such therapy
- •No symptomatic or rapidly progressive malignancy requiring therapy
- •No symptomatic CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •More than 2 months
- •Hematopoietic
- •WBC at least 2,500/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 50,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Hematocrit at least 30%
- •Bilirubin no greater than 3.0 mg/dL (unless due to Gilbert's disease)
- •SGOT and SGPT no greater than 3 times upper limit of normal
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine no greater than 2.0 mg/dL
- •Immunologic
- •HIV negative
- •Rheumatoid factor negative if history or evidence of arthritis
- •Anti-nuclear antibody (ANA) titer no greater than 1:80 if history or clinical signs or symptoms of connective tissue disease
- •No prior or active autoimmune disease (e.g., uveitis, rheumatoid arthritis, lupus erythematosus, autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders [e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency], sarcoid granuloma, myasthenia gravis, polymyositis,or Guillain-Barre syndrome)
- •No positive antibody titers to autoimmune diseases
- •Rheumatoid factor positive allowed unless ANA titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease
- •No active infection
- •No other active malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer
- •Not pregnant or nursing
- 另有 23 项未显示
排除标准
- 未提供
结局指标
主要结局
Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment
次要结局
- T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment
研究者
研究点 (2)
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