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

Primary Purpose

Hodgkin Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Avastin
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Avastin, bevacizumab, ABVD, angiogenesis, antiangiogenic, Hodgkin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Avastin (Bevacizumab)

Arm Description

single-arm, open-label

Outcomes

Primary Outcome Measures

Failure-free Survival
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
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
Progression-free survival: a patient lives with the disease but it does not get worse.
Overall Survival
Overall survival: patients are still alive.
Safety
Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)

Full Information

First Posted
July 24, 2008
Last Updated
September 18, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00722865
Brief Title
Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma
Official Title
Avastin (Bevacizumab) in Combination With ABVD for the Treatment of Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Avastin, bevacizumab, ABVD, angiogenesis, antiangiogenic, Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avastin (Bevacizumab)
Arm Type
Other
Arm Description
single-arm, open-label
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
Bevacizumab
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.
Primary Outcome Measure Information:
Title
Failure-free Survival
Description
Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy
Time Frame
2 years and median follow-up of 18 months
Secondary Outcome Measure Information:
Title
Overall Response Rate Using the Modified Cheson Criteria
Description
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
Time Frame
2 years
Title
Progression-free Survival
Description
Progression-free survival: a patient lives with the disease but it does not get worse.
Time Frame
2 years and medium follow-up of 18 months
Title
Overall Survival
Description
Overall survival: patients are still alive.
Time Frame
2 years
Title
Safety
Description
Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Abramson, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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