Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Avastin
Intervention description: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avastin; bevacizumab; ABVD; angiogenesis; antiangiogenic; Hodgkin

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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