A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Response (CR or PR)
研究概览
简要总结
This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory chronic lymphocytic leukemia. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die
详细描述
OBJECTIVES:
I. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed chronic lymphocytic leukemia.
OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic lymphocytic leukemia [CLL] vs transformed CLL).
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic lymphocytic leukemia (CLL)
- •Relapsed, refractory, or transformed disease
- •Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression
- •Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody
- •Transformed CLL (Richters transformation), must meet both of the following criteria:
- •Histologically confirmed lymphoma
- •Measurable disease
- •No CNS disease
- •Performance status - ECOG 0-2
- •Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease)
- •SGOT and SGPT < 3 times upper limit of normal
- •Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement)
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •See Disease Characteristics
- •No concurrent prophylactic hematopoietic colony-stimulating factors
- •See Disease Characteristics
- •More than 2 weeks since prior cytotoxic chemotherapy and recovered
- •More than 2 weeks since prior radiotherapy and recovered
- •No other concurrent investigational or antitumor agents
- •No other concurrent cytotoxic agents
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.
干预措施: temsirolimus (Drug)
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response (CR or PR)
时间窗: 6 months
Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).
次要结局
未报告次要终点