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

NCT00722865 | Terminated Phase 2 Results DMC

• 1 other identifier: 07-388
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Keywords

Avastin; bevacizumab; ABVD; angiogenesis; antiangiogenic; Hodgkin

Outcome Measures

Primary Outcomes (1)

• Failure-free Survival

  Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy

  2 years and median follow-up of 18 months

Secondary Outcomes (4)

• Overall Response Rate Using the Modified Cheson Criteria

  2 years

• Progression-free Survival

  2 years and medium follow-up of 18 months

• Overall Survival

  2 years

• Safety

  2 years

Study Arms (1)

Avastin (Bevacizumab)

OTHER

single-arm, open-label

Drug: Avastin

Interventions

Avastin DRUG

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.

Also known as: Bevacizumab

Avastin (Bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jeremy Abramson, MD
• Organization: Massachusetts General Hospital Cancer Center

jabramson@mgh.harvard.edu

617-724-4000

Study Officials

• Jeremy Abramson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lymphoma Program

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 18, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-09

Locations

US (1)