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Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma

This study has been terminated.
(slow enrollment)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00722865
First received: July 24, 2008
Last updated: March 17, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Hodgkin Lymphoma Drug: Avastin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Avastin (Bevacizumab) in Combination With ABVD for the Treatment of Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Jeremy Abramson, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Failure-free Survival [ Time Frame: 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


Secondary Outcome Measures:
  • Overall Response Rate Using the Modified Cheson Criteria [ Time Frame: 2 years ]
    Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT

  • Progression-free Survival [ Time Frame: 2 years and medium follow-up of 18 months ]
    Progression-free survival: a patient lives with the disease but it does not get worse.

  • Overall Survival [ Time Frame: 2 years ]
    Overall survival: patients are still alive.

  • Safety [ Time Frame: 2 years ]
    Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)


Enrollment: 25
Study Start Date: September 2008
Estimated Study Completion Date: November 2017
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Avastin (Bevacizumab)
single-arm, open-label
Drug: Avastin
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.
Other Name: Bevacizumab

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722865

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Genentech, Inc.
Investigators
Principal Investigator: Jeremy Abramson, MD Massachusetts General Hospital
  More Information

Responsible Party: Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00722865     History of Changes
Other Study ID Numbers: 07-388
Study First Received: July 24, 2008
Results First Received: January 25, 2017
Last Updated: March 17, 2017

Keywords provided by Jeremy Abramson, MD, Massachusetts General Hospital:
Avastin
bevacizumab
ABVD
angiogenesis
antiangiogenic
Hodgkin

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bevacizumab
Bleomycin
Doxorubicin
Vinblastine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on June 23, 2017