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Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02490878
Recruitment Status : Active, not recruiting
First Posted : July 7, 2015
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

Condition or disease Intervention/treatment Phase
Radionecrosis Brain Metastases Drug: bevacizumab Drug: corticosteroids Other: placebo Phase 2

Detailed Description:

This is a randomized double-blinded phase II study of corticosteroids with bevacizumab vs. corticosteroids with placebo for brain radionecrosis following radiosurgery for brain metastases. This is a two-arm clinical trial with parallel group design for longitudinal quality of life endpoint. Patients will be stratified according to age (≤ 65 years vs. > 65 years), pathological confirmation of necrosis (yes vs. no), MDASI-BT mean global score (symptom + interference scores) ( < 4.0 vs. > 4.0) and prior whole brain radiotherapy (yes vs. no). The primary and secondary objectives are detailed below.

Primary Objective:

To investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms (clinical and patient-reported symptom improvement associated with radionecrosis and less radionecrosis treatment-induced symptoms) compared with standard corticosteroid therapy.

Secondary Objectives:

  1. To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy.
  2. To compare self-reported health related quality of life (HRQOL) using LASA, Dexamethasone Symptoms Questionnaire-Chronic (DSQ-C), and MDASI-BT symptom and interference score between treatment arms.
  3. To compare intracranial progression-free survival and time to maximum radiographic response between treatment arms.
  4. To compare the dose and duration of corticosteroids required between treatment arms and correlate steroid requirement with DSQ-C and MDASI-BT scores.

Patient event monitoring will occur every 2 months after treatment up to 6 months. Then event monitoring will occur up to one year.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases
Study Start Date : April 2016
Estimated Primary Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: bevacizumab + corticosteroids

The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.

Patients who meet the criteria for clinical progression will be treated as per treating MD.

Drug: bevacizumab
IV

Drug: corticosteroids
IV

Experimental: placebo + corticosteroids

The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.

Patients who meet the criteria for clinical progression will be allowed to receive bevacizumab according to the protocol.

Drug: corticosteroids
IV

Other: placebo
IV




Primary Outcome Measures :
  1. Patient-reported outcome (symptoms) of radionecrosis [ Time Frame: Up to 8 weeks ]

Secondary Outcome Measures :
  1. Toxicities associated with bevacizumab and corticosteroids in patients with radionecrosis using CTCAE Version 4.0 and DSQ-C. [ Time Frame: Up to 1.5 years post-treatment ]
  2. Quality of life measure using the Single Item Linear Analogue Scale (LASA) [ Time Frame: Up to 1.5 years post-treatment ]
  3. Quality of life measure using the Dexamethasone Symptoms Questionnaire - Chronic (DSQ-C) [ Time Frame: Up to 1.5 years post-treatment ]
  4. Quality of life measure using the The M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) score. [ Time Frame: Up to 1.5 years post-treatment ]
  5. Progression free survival [ Time Frame: Up to 16 weeks ]
  6. Corticosteroid dose over time [ Time Frame: Up to 16 weeks ]
  7. Maximum radiographic response [ Time Frame: Up to 16 weeks ]
  8. Time to stopping corticosteroids [ Time Frame: Up to 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Pre-Registration Eligibility Criteria:

  1. Patients who present with symptomatic brain radionecrosis after they have received radiosurgery for brain metastases from primary solid tumor including but not limited to lung, breast, colorectal cancer but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas
  2. Patients at institutions that elect to utilize central imaging review to confirm eligibility must be pre-registered prior to submission of these images; images should be submitted as soon as possible after the pre-registration magnetic resonance imaging (MRI) is obtained; turnaround time for this review will be =< 72 business hours after receipt of images by the Imaging and Radiation Oncology Core (IROC)
  3. Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized

Registration/Randomization Eligibility Criteria:

  1. A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation.

    1.1 'Symptomatic' brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where 'symptomatic' is defined as:

    1.1.1 New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits

    1.1.2 Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg (or equivalent corticosteroid) daily for 1 week

    1.2 Clinical eligibility supported by central imaging real-time review. The presence of at least the following conventional MR image characteristic:

    1.2.1 Conventional MR - Lesion quotient of < 0.3, where lesion quotient is defined as the proportional value of the maximum axial cross-sectional area of the T2-weighted defined lesion over the maximum axial cross-sectional area of the contrast-enhancing lesion on the T1-weighted post-gadolinium sequence on a comparable axial slice. If the conventional MR findings are not seen, the following dynamic susceptibility-contrast (DSC) MR characteristics may be used to meet eligibility for this study.

    1.2.2 DSC MR - The cut-offs below will be based on GRE EPI DSC perfusion images, acquired without using a gadolinium pre-load:

    1.2.2.1 Relative cerebral blood volume (rCBV) <1.5 in the enhancing- lesion relative to normal-appearing white matter (NAWM)

    1.2.2.2. Percentage of signal recovery (PSR) > 76%, where PSR is determined by comparing the lower signal intensity during passage of the contrast bolus with the post-contrast signal intensity on the signal intensity-time curve

    1.2.3 Centers that standardly use PET or MRS to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility. Both PET and MRS are not mandatory for study eligibility.

  2. Prior to start of treatment

    2.1 Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI.

    2.2 No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration. The protocol provides a list of 'approved systemic' therapies that are allowed for concurrent use with bevacizumab.

    2.3 No bevacizumab ≤ 3 months of study registration.

    2.4 Central imaging real-time review (72 hour turn around) to confirm eligibility.

  3. Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 14 days prior to registration and confirmation they are not nursing is required.
  4. Age ≥ 18 years
  5. Karnofsky Performance Status ≥ 60%
  6. Required Initial Laboratory Values ≤14 days of registration:

    6.1 Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3

    6.2 Platelet Count ≥ 100,000/mm3

    6.3 Hemoglobin ≥ 10 g/dL*

    6.3.1 allowing transfusion or other intervention to achieve this minimum hemoglobin

    6.4 BUN < 30 mg/dL

    6.5 Creatinine < 1.7 mg/dL

    6.6 Bilirubin ≤ 2.0 mg/dL

    6.7 ALT ≤ 3.0 x upper limits of normal (ULN)

    6.8 AST ≤ 3.0 x ULN

    6.9 INR <1.5 x ULN**

    6.9.1 unless patients are receiving anti-coagulation therapy. Patients receiving anti-coagulation therapy with an agent such warfarin or heparin are allowed to participate if INR ≤ 3.0.**

    6.10 UPC Ratio <0.5 or if ≥ 0.5

    6.10.1 24-hour urine protein must be <1000 mg

  7. Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires.

    Assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult.

  8. No evidence of recent hemorrhage at pre-registration MRI of the brain, however the following are permitted: presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor.
  9. No excess risk of bleeding (any of the following):

    9.1 Bleeding diathesis or coagulopathy

    9.2 Thrombocytopenia

    9.3 Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days or anticipation of need for major surgical procedure during the course of the study.

    9.4 Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core biopsy within the past 7 days.

  10. No clinically significant cardiovascular disease.

    10.1 No uncontrolled hypertension (systolic blood pressure ≤ 160 mm Hg or diastolic ≤ 100 mm Hg). Patients with hypertension must be adequately controlled with appropriate anti-hypertensive therapy or diet.

    10.2 No history of arterial thrombotic events within the past 6 months, including:

    10.2.1 transient ischemic attack (TIA)

    10.2.2 cerebrovascular accident (CVA)

    10.2.3 peripheral arterial thrombus

    10.2.4 unstable angina or angina requiring surgical or medial intervention

    10.2.5 myocardial infarction (MI)

    10.2.6 significant peripheral artery disease (i.e., claudication on less than one block)

    10.2.7 significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)

    10.3 Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation.

    10.4 No current New York Heart Association classification II, III, or IV congestive heart failure.

  11. No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within past 12 months.
  12. No central lung metastases with excessive active bleeding.
  13. No uncontrolled intercurrent illness including, but not limited to any of the following:

    ongoing or active infection requiring IV antibiotics, cardiac arrhythmia, or psychiatric illness and/or social situations that would limit compliance with study requirements.

  14. No history of serious non-healing wound, ulcer, or bone fractures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490878


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Locations
United States, Alaska
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, California
PCR Oncology
Arroyo Grande, California, United States, 93420
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Halifax Health Medical Center-Centers for Oncology
Daytona Beach, Florida, United States, 32114
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
University Cancer and Blood Center LLC
Athens, Georgia, United States, 30607
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Summit Cancer Care-Memorial
Savannah, Georgia, United States, 31404
Low Country Cancer Care Associates PC
Savannah, Georgia, United States, 31405
Summit Cancer Care-Candler
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Walter Knox Memorial Hospital
Emmett, Idaho, United States, 83617
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, United States, 83686
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois
Chicago, Illinois, United States, 60612
Carle on Vermilion
Danville, Illinois, United States, 61832
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Community Cancer Center East
Indianapolis, Indiana, United States, 46219
Community Cancer Center South
Indianapolis, Indiana, United States, 46227
Community Cancer Center North
Indianapolis, Indiana, United States, 46256
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, United States, 46545
Chancellor Center for Oncology
Newburgh, Indiana, United States, 47630
Reid Health
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Trinity Regional Medical Center
Fort Dodge, Iowa, United States, 50501
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Central Care Cancer Center - Garden City
Garden City, Kansas, United States, 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States, 67530
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, United States, 66219
Minimally Invasive Surgery Hospital
Lenexa, Kansas, United States, 66219
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
United States, Massachusetts
Mercy Medical Center
Springfield, Massachusetts, United States, 01104
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, United States, 48114
Saint Joseph Mercy Brighton
Brighton, Michigan, United States, 48114
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, United States, 48188
Saint Joseph Mercy Canton
Canton, Michigan, United States, 48188
Caro Cancer Center
Caro, Michigan, United States, 48723
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, United States, 48118
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States, 48118
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States, 48346
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Ascension Saint John Hospital
Detroit, Michigan, United States, 48236
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, United States, 48054
Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan, United States, 48336
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, United States, 48503
Genesee Hematology Oncology PC
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, United States, 48236
Lymphoma Clinic of Michigan
Grosse Pointe Woods, Michigan, United States, 48236
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, United States, 48236
William Beaumont Hospital-Grosse Point
Grosse Pointe, Michigan, United States, 48230
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Hope Cancer Clinic
Livonia, Michigan, United States, 48154
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, United States, 48044
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, United States, 48044
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, United States, 48453
Ascension Providence Hospitals - Novi
Novi, Michigan, United States, 48374
21st Century Oncology-Pontiac
Pontiac, Michigan, United States, 48341
Hope Cancer Center
Pontiac, Michigan, United States, 48341
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States, 48341
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Huron Medical Center PC
Port Huron, Michigan, United States, 48060
Lake Huron Medical Center
Port Huron, Michigan, United States, 48060
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, United States, 48309
Michigan Cancer Specialists
Roseville, Michigan, United States, 48066
Oakland Colon and Rectal Association
Royal Oak, Michigan, United States, 48067
Cancer Care Associates PC
Royal Oak, Michigan, United States, 48073
Comprehensive Medical Center PLLC
Royal Oak, Michigan, United States, 48073
Hematology Oncology Consultants PC
Royal Oak, Michigan, United States, 48073
Oakland Medical Group
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States, 48604
Ascension Providence Hospitals - Southfield
Southfield, Michigan, United States, 48075
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, United States, 48312
Premier Hematology Oncology Care
Sterling Heights, Michigan, United States, 48312
Mitchell Folbe MD PC
Sterling Heights, Michigan, United States, 48314
Saint Joseph Health System-Tawas City
Tawas City, Michigan, United States, 48764
Michigan Institute of Urology-Town Center
Troy, Michigan, United States, 48084
Claudia BR Herke MD PC
Troy, Michigan, United States, 48085
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085
Hematology Oncology Consultants PC-Troy
Troy, Michigan, United States, 48098
Advanced Breast Care Center PLLC
Warren, Michigan, United States, 48088
Bhadresh Nayak MD PC-Warren
Warren, Michigan, United States, 48093
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, United States, 48093
Macomb Hematology Oncology PC
Warren, Michigan, United States, 48093
Michigan Breast Specialists-Warren
Warren, Michigan, United States, 48093
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States, 48661
Huron Gastroenterology PC
Ypsilanti, Michigan, United States, 48106
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States, 56501
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States, 56537
Essentia Health - Fosston
Fosston, Minnesota, United States, 56542
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Essentia Health - Park Rapids
Park Rapids, Minnesota, United States, 56470
Mayo Clinic
Rochester, Minnesota, United States, 55905
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
United States, Missouri
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States, 63011
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States, 65613
Cox Cancer Center Branson
Branson, Missouri, United States, 65616
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Freeman Health System
Joplin, Missouri, United States, 64804
Mercy Hospital Joplin
Joplin, Missouri, United States, 64804
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64507
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, United States, 63376
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Washington
Washington, Missouri, United States, 63090
United States, Montana
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nevada
Carson Tahoe Regional Medical Center
Carson City, Nevada, United States, 89703
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, United States, 89052
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States, 89052
Nevada Cancer Specialists-Saint Rose
Henderson, Nevada, United States, 89052
21st Century Oncology-Henderson
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States, 89074
Desert West Surgery
Las Vegas, Nevada, United States, 89102
Nevada Cancer Specialists?Oakey
Las Vegas, Nevada, United States, 89102
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, United States, 89106
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States, 89106
21st Century Oncology
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States, 89113
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States, 89119
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, United States, 89121
21st Century Oncology-Vegas Tenaya
Las Vegas, Nevada, United States, 89128
Ann M Wierman MD LTD
Las Vegas, Nevada, United States, 89128
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States, 89128
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States, 89128
Nevada Cancer Specialists-Tenaya
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States, 89144
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States, 89148-2405
21st Century Oncology-Fort Apache
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Nevada Cancer Specialists-Fort Apache
Las Vegas, Nevada, United States, 89148
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States, 89149
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States, 89169
University Cancer Center
Las Vegas, Nevada, United States, 89169
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, United States, 89048
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
Radiation Oncology Associates
Reno, Nevada, United States, 89509
United States, New Hampshire
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States, 03301
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States, 27215
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States, 28328
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
East Carolina University
Greenville, North Carolina, United States, 27834
Onslow Memorial Hospital
Jacksonville, North Carolina, United States, 28546
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States, 28546
Cone Heath Cancer Center at Mebane
Mebane, North Carolina, United States, 27302
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States, 27320
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States, 27893
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, United States, 58401
United States, Ohio
Cleveland Clinic Akron General
Akron, Ohio, United States, 44307
Indu and Raj Soin Medical Center
Beavercreek, Ohio, United States, 45431
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States, 45459
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States, 45236
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Dayton Physicians LLC-Samaritan North
Dayton, Ohio, United States, 45415
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Armes Family Cancer Center
Findlay, Ohio, United States, 45840
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Orion Cancer Care
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States, 45005
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States, 45331
Wayne Hospital
Greenville, Ohio, United States, 45331
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
First Dayton Cancer Care
Kettering, Ohio, United States, 45420
Kettering Medical Center
Kettering, Ohio, United States, 45429
Dayton Physicians LLC-Signal Point
Middletown, Ohio, United States, 45042
Dayton Physicians LLC-Wilson
Sidney, Ohio, United States, 45365
Springfield Regional Cancer Center
Springfield, Ohio, United States, 45504
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Dayton Physicians LLC-Upper Valley
Troy, Ohio, United States, 45373
Upper Valley Medical Center
Troy, Ohio, United States, 45373
United States, Oklahoma
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, United States, 97814
Saint Charles Health System
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States, 97015
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, United States, 97914
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States, 19317
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
Charleston Hematology Oncology Associates-Roper
Charleston, South Carolina, United States, 29403
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina, United States, 29406
Bon Secours Saint Francis Hospital
Charleston, South Carolina, United States, 29414
Charleston Hematology Oncology Associates PA-Saint Francis
Charleston, South Carolina, United States, 29414
Lowcountry Hematology Oncology PA-West Ashley
Charleston, South Carolina, United States, 29414
Greenville Health System Cancer Institute-Laurens
Clinton, South Carolina, United States, 29325
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Lowcountry Hematology Oncology PA-Mount Pleasant
Mount Pleasant, South Carolina, United States, 29464
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, United States, 37067
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States, 98520
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Swedish Medical Center-Edmonds
Edmonds, Washington, United States, 98026
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Providence Regional Cancer System-Lacey
Lacey, Washington, United States, 98503
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States, 98107
Kaiser Permanente Washington
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States, 98122-5711
Providence Regional Cancer System-Shelton
Shelton, Washington, United States, 98584
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, United States, 99216
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States, 99204
Rockwood North Cancer Treatment Center
Spokane, Washington, United States, 99218
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
Providence Regional Cancer System-Yelm
Yelm, Washington, United States, 98597
United States, West Virginia
United Hospital Center
Bridgeport, West Virginia, United States, 26330
WVUH-Berkely Medical Center
Martinsburg, West Virginia, United States, 25401
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Camden Clark Medical Center
Parkersburg, West Virginia, United States, 26101
United States, Wisconsin
Ashland Memorial Medical Center
Ashland, Wisconsin, United States, 54806
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
United States, Wyoming
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Genentech, Inc.
Investigators
Study Chair: Caroline Chung, MD M.D. Anderson Cancer Center

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02490878     History of Changes
Obsolete Identifiers: NCT02531659
Other Study ID Numbers: A221208
NCI-2015-01348 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents