A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
研究概览
简要总结
Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
详细描述
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.
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
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: temsirolimus (Drug)
结局指标
主要结局
Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
时间窗: Up to 24 weeks
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.
次要结局
- Time to progression(Time from registration to the time of progression, assessed up to 5 years)
- Overall survival(Time from registration to death due to any cause, assessed up to 5 years)
- Progression-free survival(Time from registration to progression or death due to any cause, assessed up to 5 years)
- Duration of response(From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years)