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slow enrollment
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin (Bevacizumab) | Other | single-arm, open-label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Abramson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Avastin (Bevacizumab) | single-arm, open-label 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avastin (Bevacizumab) | single-arm, open-label 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Failure-free Survival | Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy | Posted | Number | 90% Confidence Interval | percentage of participants | 2 years and median follow-up of 18 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avastin (Bevacizumab) | single-arm, open-label 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensory Neuropathy | Nervous system disorders | grade 4, expected and definitely related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Abramson, MD | Massachusetts General Hospital Cancer Center | 617-724-4000 | jabramson@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| 2 years |
| 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 |
| Overall Survival | Overall survival: patients are still alive. | 2 years |
| Safety | Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening) | 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stage of Cancer | Count of Participants | Participants |
|
| Hemoglobin | Count of Participants | Participants |
|
| Leukocytosis | Count of Participants | Participants |
|
| Absolute lymphocyte count | Count of Participants | Participants |
|
| Albumin | Count of Participants | Participants |
|
| B symptoms | B symptoms refer to systemic symptoms of fever, night sweats, and weight loss which can be associated with both Hodgkin's lymphoma and non-Hodgkin's lymphoma. The presence or absence of B symptoms has prognostic significance and is reflected in the staging of these lymphomas. | Count of Participants | Participants |
|
| International Prognostic Scoring System (IPSS) | Risk score: 0-1= very low, 2 = low, 3 = intermediate, 4-5=high | Count of Participants | Participants |
|
|
| 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 | Posted | Number | 90% Confidence Interval | percentage of participants | 2 years |
|
|
|
| Secondary | Progression-free Survival | Progression-free survival: a patient lives with the disease but it does not get worse. | Posted | Number | 90% Confidence Interval | percentage of participants | 2 years and medium follow-up of 18 months |
|
|
|
| Secondary | Overall Survival | Overall survival: patients are still alive. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Safety | Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening) | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 4 |
| 25 |
| 25 |
| 25 |
| Soft Tissue Necrosis | Musculoskeletal and connective tissue disorders | grade 4, possibly related, expected |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | grade 4, possibly related, expected |
|
| Pericardial Effusion | Cardiac disorders | grade 3, possibly related, expected |
|
| Platelets | Blood and lymphatic system disorders |
|
| Chills | General disorders |
|
| Febrile neutropenia | Blood and lymphatic system disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Leukocytosis | Blood and lymphatic system disorders |
|
| Head/headache | General disorders |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders |
|
| Jejunal fistula | Gastrointestinal disorders |
|
| Pain of skin | Skin and subcutaneous tissue disorders |
|
| Anal hemorrhage | Gastrointestinal disorders |
|
| Movements involuntary | Nervous system disorders |
|
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders |
|
| Abdomen- pain | General disorders |
|
| Back- pain | General disorders |
|
| Hypercalcemia | Metabolism and nutrition disorders |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
|
| Anorectal infection | Infections and infestations |
|
| Edema face | General disorders |
|
| Gastritis | Gastrointestinal disorders |
|
| Extremity-limb- pain | General disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Nose- hemorrhage | Blood and lymphatic system disorders |
|
| Conduction disorder | Cardiac disorders |
|
| Hypertension | Cardiac disorders |
|
| Death neonatal | General disorders |
|
| Ileal obstruction | Gastrointestinal disorders |
|
| Edema cerebral | Nervous system disorders |
|
| Periorbital edema | Skin and subcutaneous tissue disorders |
|
| Neck- pain | General disorders |
|
| Pericardial effusion (non-malignant) | Cardiac disorders |
|
| Alkalosis | Metabolism and nutrition disorders |
|
| Fatigue | General disorders |
|
| Infection Gr0-2 neut, upper airway | Infections and infestations |
|
| Joint, pain | General disorders |
|
| Pain-other | General disorders |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders |
|
| Myocarditis | Cardiac disorders |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Wound infection | Infections and infestations |
|
| Infections and infestations - Other, specify | Infections and infestations |
|
| Chest wall, pain | General disorders |
|
| Throat/pharynx/larynx- pain | General disorders |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Thrombocytopenia |
|
| Febrile neutropenia |
|
| Hypertension |
|
| Proteinuria |
|
| Pericardial effusion |
|
| Pleural effusion |
|
| Skin breakdown |
|
| Mucositis |
|
| Sensory neuropathy |
|
| Thrombosis/embolism |
|
| Renal failure |
|
| Fatigue |
|