CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
研究概览
详细说明
OBJECTIVES:
I. Determine the objective responses in patients with previously treated mantle cell non-Hodgkin's lymphoma treated with CCI-779.
II. Determine the toxic effects of this drug in these patients. III. Determine whether this drug inhibits cell proliferation pathways in these patients.
OUTLINE:
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. Patients with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- North Central Cancer Treatment Group
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)
- Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy
Unidimensionally measurable lymph node or lesion
- At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam
One of the following measurement parameters may be used:
- Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
- Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm^3
- No known CNS involvement (parenchymal mass or leptomeningeal involvement)
- Performance status - ECOG 0-2
- At least 3 months
- See Disease Characteristics
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 8 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Direct bilirubin ≤ 1.5 times ULN
- AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
- Creatinine ≤ 2 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Cholesterol ≤ 350 mg/dL
- Triglycerides ≤ 400 mg/dL
- HIV negative
- No other active malignancy requiring treatment or that would preclude study participation
- No other concurrent uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- See Disease Characteristics
- Prior high-dose therapy with stem cell transplantation allowed
- At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers
- See Disease Characteristics
- See Biologic therapy
- At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy for MCL
- Concurrent corticosteroids for adrenal insufficiency allowed
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy for MCL
- Any number of prior treatments allowed
- No other concurrent investigational or commercial agents for MCL
- No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide)
- No concurrent immunosuppressive therapies
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment
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.
Patients with stable disease receive a maximum of 6 courses.
Patients with partial response receive a maximum of 12 courses.
Patients with CR receive 2 additional courses beyond CR.
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鉴于IV
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
大体时间:Up to 24 weeks
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The proportion will be evaluated separately for each dose group.
The proportion of patients who achieve a confirmed CR or PR, or success, will be estimated by the number of successes divided by the total number of evaluable patients.
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
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Up to 24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
无进展生存期
大体时间:从注册到进展或因任何原因死亡的时间,评估长达 5 年
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将使用 Kaplan-Meier 方法估计无进展生存期的分布。
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从注册到进展或因任何原因死亡的时间,评估长达 5 年
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Time to progression
大体时间:Time from registration to the time of progression, assessed up to 5 years
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The distribution of time to progression will be estimated using the method of Kaplan-Meier.
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Time from registration to the time of progression, assessed up to 5 years
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Overall survival
大体时间:Time from registration to death due to any cause, assessed up to 5 years
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The distribution of overall survival will be estimated using the method of Kaplan-Meier.
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Time from registration to death due to any cause, assessed up to 5 years
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Duration of response
大体时间:From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years
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From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years
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合作者和调查者
调查人员
- 首席研究员:Stephen Ansell、North Central Cancer Treatment Group
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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