NCT00544999Unknown1 期
Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse
Institut de Recherche Clinique sur les Cancers et le Sang2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of everolimus.
- Determine the toxicity of this regimen.
Secondary
- Assess the activation of PI3K/AKT and mTORC 1 in leukemic blasts.
- Evaluate the pharmacokinetics of everolimus at different concentrations.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:
- •Relapse > 1 year after obtaining complete remission (any prior treatment allowed)
排除标准
- •Philadelphia chromosome-positive disease in blast crisis
- •FAB M3, M6, or M7 disease
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •Life expectancy ≥ 4 weeks
- •Transaminases ≤ 5 times normal
- •Creatinine ≤ 2 times normal
- •Bilirubin ≤ 3 times normal (except if visceral involvement present)
- •Alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy
- •Exclusion criteria:
- •FEV1 < 30%
- •Active uncontrolled or viral pulmonary infection
- •Serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
- •HIV-positive
- •Other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
- •Patients who are incarcerated or under supervision or trusteeship
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •See Disease Characteristics
- •Exclusion criteria:
- •Prior experimental medication within the past 4 weeks
结局指标
主要结局
Toxicity
Maximum tolerated dose of everolimus
次要结局
- Activation of PI3K/AKT and mTORC 1 in leukemic blasts
- Pharmacokinetics of everolimus
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid LeukemiaLeukemiaNCT00814164Roswell Park Cancer Institute21
已完成
1 期
Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid LeukemiaLeukemiaNCT00107523Fred Hutchinson Cancer Center
已完成
2 期
S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid LeukemiaLeukemiaNCT00066794SWOG Cancer Research Network69
已完成
2 期
S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic LeukemiaLeukemiaNCT00337168SWOG Cancer Research Network36
已完成
1 期
Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic LeukemiaLeukemiaNCT00295841Wake Forest University Health Sciences53