NCT00727207终止2 期
Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well everolimus works in treating older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.
详细描述
OBJECTIVES:
Primary
- Determine the progression-free survival of older patients with mantle cell lymphoma receiving everolimus and who were previously treated with first- or second-line chemotherapy.
Secondary
- Determine the toxicity and feasibility of treatment with this drug.
- Determine the efficacy of this drug in these patients.
- Compare the duration of remission after first- vs second-line chemotherapy.
- Determine the rate of objective remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of mantle cell lymphoma
- •Stable disease after first- or second-line chemotherapy
- •No uncontrolled cerebral or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy ≥ 3 months
- •Age ≥ 60 years or patients ≥ 40 and < 60 years who are not suitable for high-dose chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell transplantation
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin > 9 g/dL
- •Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- •SGPT and SGOT ≤ 3 times ULN
- •Bilirubin ≤ 1.5 times ULN
- •No other malignancies within the past 3 years except treated cervical carcinoma or basal cell cancer
- •No other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled hypertension, serious infections, serious malnutrition, unstable angina pectoris, weak heart, myocardial infarction within the past 6 months, chronic liver illness, active ulceration in the gastrointestinal tract, psychiatric illness)
- •No known HIV infection
- •No gastrointestinal disturbances that could influence the absorption of everolimus and cause short-intestine syndrome (e.g., atrophic gastritis)
- •No coagulation or bleeding diatheses
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Patients must have complied with their previous drug prescription
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •See Patient Characteristics
- •Recovered from all prior therapy
- •At least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy
- •More than 4 weeks since prior experimental medication
- •No chronic therapy with systemic steroids or other immunosuppressants except rituximab
- •No prior organ transplantation
- •No therapy with vitamin K antagonist, except low-dose coumarin
- •No prior mTOR inhibitors
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Toxicity and feasibility
- Efficacy
- Comparison of duration of remission after first- vs second-line chemotherapy
- Rate of objective remission
研究者
研究点 (2)
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