Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborator:
Genentech
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00722865
First received: July 24, 2008
Last updated: December 13, 2012
Last verified: December 2012
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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 Massachusetts General Hospital:
Primary Outcome Measures:
- To determine clinical activity and safety of bevacizumab when combined with ABVD for primary therapy of Hodgkin lymphoma [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate effect of therapy on circulating angiogenic factors and correlate with tissue expression of VEGF and receptors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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 |
| Genders Eligible for Study: | Both |
| 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
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
Investigators
| Principal Investigator: | Jeremy Abramson, MD | Massachusetts General Hospital |
More Information
No publications provided
| 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 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Avastin bevacizumab ABVD |
angiogenesis antiangiogenic Hodgkin |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dacarbazine Bevacizumab Vinblastine Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013