A Phase II Study Of CCI-779 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Response rate of 20%
研究概览
简要总结
Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase
详细描述
PRIMARY OBJECTIVES:
I. Determine the activity of CCI-779 in patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or chronic myelogenous leukemia in blastic phase.
II. Correlate the effect of this drug with altered mitochondrial respiration in the leukemia cells of these patients.
OUTLINE: Patients are stratified according to disease (acute myeloid leukemia, myelodysplastic syndromes, chronic myelogenous leukemia in blastic phase [CML-BP] non-lymphoid vs acute lymphoblastic leukemia, CML-BP lymphoid).
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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 1 of the following:
- •Acute myeloid leukemia
- •Acute lymphoblastic leukemia
- •Myelodysplastic syndromes
- •Refractory anemia with excess blasts [RAEB]
- •RAEB in transformation
- •Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood/bone marrow blasts
- •Chronic myelogenous leukemia in blastic phase
- •Disease status must meet 1 of the following criteria:
- •Primary resistant disease (i.e., failed to achieve a complete response [CR] to a prior standard induction regimen)
- •Relapsed disease after achieving a CR
- •Documented failure to most recent cytotoxic regimen
- •No other potentially curative options
- •No known CNS disease
- •Performance status - ECOG 0-2
- •SGOT or SGPT < 3 times upper limit of normal*
- •Bilirubin ≤ 2 mg/dL*
- •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
- •No prior allergic reaction 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 AIDS-defining disease
- •HIV positive allowed if CD4 counts normal
- •No other concurrent uncontrolled illness
- •No concurrent prophylactic hematopoietic colony-stimulating factors
- •More than 2 weeks since prior cytotoxic chemotherapy (except hydroxyurea) and recovered
- •More than 2 weeks since prior radiotherapy and recovered
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
- •No other concurrent anticancer agents or therapies
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. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: temsirolimus (Drug)
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate of 20%
时间窗: Up to 3 years
The 95% confidence intervals should be provided.
次要结局
未报告次要终点