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

Hodgkin Lymphoma Clinical Trial

Official title:

Avastin (Bevacizumab) in Combination With ABVD for the Treatment of Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00722865
• Other study ID #: 07-388
• Status: Terminated
• Phase: Phase 2
• First received: July 24, 2008
• Last updated: September 18, 2017
• Start date: September 2008
• Est. completion date: November 2015

Study information

• Verified date: September 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 years
Secondary	Progression-free Survival	Progression-free survival: a patient lives with the disease but it does not get worse.	2 years and medium follow-up of 18 months
Secondary	Overall Survival	Overall survival: patients are still alive.	2 years
Secondary	Safety	Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)	2 years