Primary Effusion Lymphoma: A Pilot Trial of Bevacizumab and Modified Dose-Adjusted Infusional CDE Chemotherapy Preceded by a Brief Pre-Phase Assessment of Targeted Oncolytic Virotherapy With Bortezomib, Zidovudine and Valganciclovir
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Response to therapy as measured by overall, disease-free, and progression-free survival each month
研究概览
简要总结
RATIONALE: Herpesvirus is found in the cancer cells of patients with primary effusion lymphoma. Antiviral drugs, such as zidovudine and valganciclovir, may be able to act against the herpesvirus in the cancer cells to help kill the cancer cells. Bortezomib may help the antiviral drugs kill the cancer cells. Draining the effusion removes fluid that has built up. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with antiviral therapy followed by effusion drainage, bevacizumab, and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with antiviral therapy followed by effusion drainage, bevacizumab, and combination chemotherapy works in treating patients with primary effusion lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the complete response rate in patients with previously untreated primary effusion lymphoma treated with effusion drainage and bevacizumab in combination with chemotherapy comprising cyclophosphamide, doxorubicin, and etoposide.
Secondary
- Determine the overall survival, disease-free survival, and progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in previously treated or untreated patients.
- Determine, preliminarily, the biologic effects of targeted oncolytic virotherapy comprising bortezomib, zidovudine, and valganciclovir in these patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary effusion lymphoma (PEL) involving a body cavity
- •Kaposi's sarcoma associated-herpesvirus
- •Any anatomic site or distribution of involvement allowed
- •HIV infection allowed
- •Previously treated or untreated disease
- •No mass lesions in the brain (for patients receiving bevacizumab during study treatment)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-3* NOTE: *ECOG 4 allowed if due to a mechanical effect of the PEL that can be corrected by effusion drainage resulting in improved performance status to ECOG 3 or better
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 75,000/mm^3
- •No active bleeding or coagulopathy (for patients receiving bevacizumab during study treatment)
- •AST and ALT < 3 times upper limit of normal (ULN) (6 times ULN if due to hyperalimentation)
- •Bilirubin < 2.0 mg/dL OR
- •Total bilirubin ≤ 4.5 mg/dL AND direct bilirubin < 0.4 mg/dL (for patients with Gilbert's syndrome or receiving protease-inhibitor therapy)
- •Creatinine ≤ 1.5 mg/dL OR
- •Creatinine clearance > 50 mL/min
- •Cardiovascular
- •Patients receiving bevacizumab during study treatment must meet the following criteria:
- •No deep venous or arterial thrombosis within the past 6 months
- •No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 95 mm Hg)
- •No unstable angina
- •No New York Heart Association class II-IV congestive heart failure
- •No cardiac arrhythmia requiring medication
- •No clinically significant peripheral artery disease
- •No peripheral vascular disease ≥ grade 2
- •No prior myocardial infarction
- •No transient ischemic attack or cerebral vascular accident within the past 6 months
- •No other clinically significant cardiovascular disease
- •Patients receiving bevacizumab during study treatment must meet the following criteria:
- •No uncontrolled seizure disorder
- •No CNS bleeding within the past 6 months
- •No other substantial CNS disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy requiring treatment that would preclude study treatment, including, but not limited to, any of the following:
- •Life-threatening Kaposi's sarcoma
- •Non-resectable lung cancer
- •Acute leukemia
- •No grade IV organ dysfunction unrelated to PEL
- •No infection requiring chronic systemic therapy that would preclude study treatment (except HIV, hepatitis B, or hepatitis C), including, but not limited to, any of the following:
- •Invasive aspergillosis
- •End-organ cytomegalovirus (CMV)
- •CMV retinitis (e.g., ocular implants not requiring systemic therapy) allowed if controlled with local therapy
- 另有 18 项未显示
排除标准
- 未提供
结局指标
主要结局
Response to therapy as measured by overall, disease-free, and progression-free survival each month
次要结局
- Effects of high-dose zidovudine and ganciclovir on tumor cells measured by various assays after 2 weeks of study treatment