Avastin (Bevacizumab) in Combination With ABVD for the Treatment of Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Failure-free Survival
研究概览
简要总结
The purpose of this research study is to determine the effectiveness and safety of Avastin when combined with standard chemotherapy for Hodgkin lymphoma. Avastin works differently than standard chemotherapy drugs. It is a type of protein called an antibody which binds to a substance called VEGF(Vascular Endothelial Growth Factor). VEGF stimulates the growth of the blood vessels that feed tumors and encourages tumor cell growth. VEGF is produced in excess by Hodgkin lymphoma cells, and is associated with a poorer outcome in patients with Hodgkin lymphoma. When the activity of VEGF is interrupted in multiple other cancer types, the blood vessels around the tumor cells die resulting in less nutrient delivery and death to the tumor. Blocking of VEGF has also been shown to improve delivery of chemotherapy to cancer cells, making standard chemotherapy work better. This trial uses Avastin in combination with standard chemotherapy with the goal of improving the cure rate over chemotherapy alone.
详细描述
Participants will be given Avastin as well as ABVD (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) intravenously on days 1 and 15 of a 28 day cycle. Participants will receive up to a total of 6 cycles of therapy.
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
- •18 years of age or older
- •Biopsy proven classical Hodgkin lymphoma. Classical Hodgkin lymphoma includes the subtypes of nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, and classical Hodgkin lymphoma unspecified
- •Advanced stage (Stage III or IV) disease
- •Measurable disease on cross sectional imaging
- •ECOG Performance Status 0-2
- •Adequate blood counts and organ function
排除标准
- •Pregnant or lactating women
- •Laboratory Parameters as outlined in the protocol
- •LV ejection fraction lower than normal as assessed by echocardiogram or MUGA scan
- •DLCO less than 60% as measured by pulmonary function tests
- •Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year
- •Current or recent (within 4 weeks of the first infusion of this study) participation in an experimental drug study
- •Life expectancy of less than 12 weeks
- •Inability to comply with study procedures
- •Inability to give informed consent
- •Inadequately controlled hypertension
- •Any prior history of hypertensive crisis or hypertensive encephalopathy
- •NYHA Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- •History of stroke or transient ischemic attack within 6 months prior to study enrollment
- •Known CNS involvement of Hodgkin lymphoma
- •Significant vascular disease
- •Symptomatic peripheral vascular disease
- •Evidence of bleeding diatheses or coagulopathy
- •Use of daily anticoagulant medications including warfarin, heparins, or aspirin >325mg daily
- •Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days of study enrollment
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- •Serious, non-healing wound, ulcer, or bone fracture
- •Proteinuria at screening
- •Known hypersensitivity to any component of bevacizumab
- •Pregnant or lactating
研究组 & 干预措施
Avastin (Bevacizumab)
single-arm, open-label
干预措施: Avastin (Drug)
结局指标
主要结局
Failure-free Survival
时间窗: 2 years and median follow-up of 18 months
Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy
次要结局
- Overall Response Rate Using the Modified Cheson Criteria(2 years)
- Safety(2 years)
- Progression-free Survival(2 years and medium follow-up of 18 months)
- Overall Survival(2 years)
研究者
Jeremy Abramson, MD
Director, Lymphoma Program
Massachusetts General Hospital