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

NCT02490878 | Terminated Phase 2 Results DMC

• 2 other identifiers: A221208NCI-2015-01348
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 341

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.

Conditions

Radionecrosis; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score

  The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Symptom Severity) is the average of the subscale items with 0 being "not present" and 10 being "as bad as you can imagine.", given that a specified minimum numbers of items were completed. A negative change in score from baseline to given time point indicates a worsening score.

  Baseline, 2, 4, 6 and 8 weeks

Secondary Outcomes (7)

• Toxicity (CTCAE Version 4.0)

  Up to 1.5 years post-treatment

• Quality of Life Measure Using the Single Item Linear Analogue Scale (LASA)

  Up to 1.5 years post-treatment

• Quality of Life Measure Using the Dexamethasone Symptoms Questionnaire - Chronic (DSQ-C)

  Baseline and weeks 2, 4, 6, 8 of treatment

• Quality of Life Measure Using the The M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Score.

  Up to 1.5 years post-treatment

• Progression Free Survival

  Up to 16 weeks

Study Arms (2)

bevacizumab + corticosteroids

EXPERIMENTAL

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; Drug: corticosteroids

placebo + corticosteroids

EXPERIMENTAL

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; Other: placebo

Interventions

bevacizumab DRUG

IV

bevacizumab + corticosteroids

corticosteroids DRUG

IV

bevacizumab + corticosteroids; placebo + corticosteroids

placebo OTHER

IV

placebo + corticosteroids

Eligibility Criteria

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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• Genentech, Inc.: collaborator

Study Sites (341)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508, United States

Location

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508, United States

Location

Alaska Women's Cancer Care

Anchorage, Alaska, 99508, United States

Location

Anchorage Oncology Centre

Anchorage, Alaska, 99508, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

PCR Oncology

Arroyo Grande, California, 93420, United States

Location

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Regional Hematology and Oncology PA

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

Nanticoke Memorial Hospital

Seaford, Delaware, 19973, United States

Location

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Halifax Health Medical Center-Centers for Oncology

Daytona Beach, Florida, 32114, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University Cancer and Blood Center LLC

Athens, Georgia, 30607, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Summit Cancer Care-Memorial

Savannah, Georgia, 31404, United States

Location

Low Country Cancer Care Associates PC

Savannah, Georgia, 31405, United States

Location

Summit Cancer Care-Candler

Savannah, Georgia, 31405, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

Location

Kootenai Medical Center

Coeur d'Alene, Idaho, 83814, United States

Location

Walter Knox Memorial Hospital

Emmett, Idaho, 83617, United States

Location

Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, 83619, United States

Location

Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642, United States

Location

Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, 83686, United States

Location

Saint Luke's Mountain States Tumor Institute - Nampa

Nampa, Idaho, 83686, United States

Location

Kootenai Cancer Center

Post Falls, Idaho, 83854, United States

Location

Kootenai Cancer Clinic

Sandpoint, Idaho, 83864, United States

Location

Saint Luke's Mountain States Tumor Institute-Twin Falls

Twin Falls, Idaho, 83301, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Carle on Vermilion

Danville, Illinois, 61832, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

The Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560, United States

Location

Deaconess Clinic Downtown

Evansville, Indiana, 47713, United States

Location

Community Cancer Center East

Indianapolis, Indiana, 46219, United States

Location

Community Cancer Center South

Indianapolis, Indiana, 46227, United States

Location

Community Cancer Center North

Indianapolis, Indiana, 46256, United States

Location

Community Howard Regional Health

Kokomo, Indiana, 46904, United States

Location

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, 46545, United States

Location

Chancellor Center for Oncology

Newburgh, Indiana, 47630, United States

Location

Reid Health

Richmond, Indiana, 47374, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Broadlawns Medical Center

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Trinity Regional Medical Center

Fort Dodge, Iowa, 50501, United States

Location

Methodist West Hospital

West Des Moines, Iowa, 50266-7700, United States

Location

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846, United States

Location

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530, United States

Location

Kansas Institute of Medicine Cancer and Blood Center

Lenexa, Kansas, 66219, United States

Location

Minimally Invasive Surgery Hospital

Lenexa, Kansas, 66219, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States

Location

Mercy Medical Center

Springfield, Massachusetts, 01104, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, 48114, United States

Location

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States

Location

IHA Hematology Oncology Consultants-Canton

Canton, Michigan, 48188, United States

Location

Saint Joseph Mercy Canton

Canton, Michigan, 48188, United States

Location

Caro Cancer Center

Caro, Michigan, 48723, United States

Location

IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, 48118, United States

Location

Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States

Location

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346, United States

Location

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346, United States

Location

Beaumont Hospital-Dearborn

Dearborn, Michigan, 48124, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, 48054, United States

Location

Beaumont Hospital - Farmington Hills

Farmington Hills, Michigan, 48336, United States

Location

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, 48503, United States

Location

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

William Beaumont Hospital-Grosse Point

Grosse Pointe, Michigan, 48230, United States

Location

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Lymphoma Clinic of Michigan

Grosse Pointe Woods, Michigan, 48236, United States

Location

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, Michigan, 48236, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Hope Cancer Clinic

Livonia, Michigan, 48154, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, 48044, United States

Location

Michigan Breast Specialists-Macomb Township

Macomb, Michigan, 48044, United States

Location

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, 48453, United States

Location

Ascension Providence Hospitals - Novi

Novi, Michigan, 48374, United States

Location

21st Century Oncology-Pontiac

Pontiac, Michigan, 48341, United States

Location

Hope Cancer Center

Pontiac, Michigan, 48341, United States

Location

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Huron Medical Center PC

Port Huron, Michigan, 48060, United States

Location

Lake Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

Great Lakes Cancer Management Specialists-Rochester Hills

Rochester Hills, Michigan, 48309, United States

Location

Michigan Cancer Specialists

Roseville, Michigan, 48066, United States

Location

Oakland Colon and Rectal Association

Royal Oak, Michigan, 48067, United States

Location

Cancer Care Associates PC

Royal Oak, Michigan, 48073, United States

Location

Comprehensive Medical Center PLLC

Royal Oak, Michigan, 48073, United States

Location

Hematology Oncology Consultants PC

Royal Oak, Michigan, 48073, United States

Location

Oakland Medical Group

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604, United States

Location

Ascension Providence Hospitals - Southfield

Southfield, Michigan, 48075, United States

Location

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, 48312, United States

Location

Premier Hematology Oncology Care

Sterling Heights, Michigan, 48312, United States

Location

Mitchell Folbe MD PC

Sterling Heights, Michigan, 48314, United States

Location

Saint Joseph Health System-Tawas City

Tawas City, Michigan, 48764, United States

Location

Michigan Institute of Urology-Town Center

Troy, Michigan, 48084, United States

Location

Claudia BR Herke MD PC

Troy, Michigan, 48085, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48085, United States

Location

Hematology Oncology Consultants PC-Troy

Troy, Michigan, 48098, United States

Location

Advanced Breast Care Center PLLC

Warren, Michigan, 48088, United States

Location

Bhadresh Nayak MD PC-Warren

Warren, Michigan, 48093, United States

Location

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, 48093, United States

Location

Macomb Hematology Oncology PC

Warren, Michigan, 48093, United States

Location

Michigan Breast Specialists-Warren

Warren, Michigan, 48093, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661, United States

Location

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

Location

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, 48197, United States

Location

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

Location

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

Miller-Dwan Hospital

Duluth, Minnesota, 55805, United States

Location

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls, Minnesota, 56537, United States

Location

Essentia Health - Fosston

Fosston, Minnesota, 56542, United States

Location

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

Location

Essentia Health - Park Rapids

Park Rapids, Minnesota, 56470, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

Location

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

Location

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

Cox Cancer Center Branson

Branson, Missouri, 65616, United States

Location

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

Location

Centerpoint Medical Center LLC

Independence, Missouri, 64057, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64507, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, 63109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital Washington

Washington, Missouri, 63090, United States

Location

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Saint Peter's Community Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Hospital

Missoula, Montana, 59804, United States

Location

Carson Tahoe Regional Medical Center

Carson City, Nevada, 89703, United States

Location

Cancer and Blood Specialists-Henderson

Henderson, Nevada, 89052, United States

Location

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States

Location

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, 89052, United States

Location

Las Vegas Cancer Center-Henderson

Henderson, Nevada, 89052, United States

Location

Nevada Cancer Specialists-Saint Rose

Henderson, Nevada, 89052, United States

Location

21st Century Oncology-Henderson

Henderson, Nevada, 89074, United States

Location

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, 89074, United States

Location

Desert West Surgery

Las Vegas, Nevada, 89102, United States

Location

Nevada Cancer Specialists?Oakey

Las Vegas, Nevada, 89102, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, 89106, United States

Location

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106, United States

Location

21st Century Oncology

Las Vegas, Nevada, 89109, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, 89109, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, 89113, United States

Location

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, 89119, United States

Location

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, 89121, United States

Location

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, 89128, United States

Location

Ann M Wierman MD LTD

Las Vegas, Nevada, 89128, United States

Location

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, 89128, United States

Location

Nevada Cancer Specialists-Tenaya

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144, United States

Location

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

Location

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, 89148-2405, United States

Location

21st Century Oncology-Fort Apache

Las Vegas, Nevada, 89148, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

Nevada Cancer Specialists-Fort Apache

Las Vegas, Nevada, 89148, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, 89149, United States

Location

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169, United States

Location

University Cancer Center

Las Vegas, Nevada, 89169, United States

Location

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, 89048, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Saint Mary's Regional Medical Center

Reno, Nevada, 89503, United States

Location

Radiation Oncology Associates

Reno, Nevada, 89509, United States

Location

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301, United States

Location

New Hampshire Oncology Hematology PA-Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203, United States

Location

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, 27215, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Onslow Memorial Hospital

Jacksonville, North Carolina, 28546, United States

Location

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States

Location

Cone Heath Cancer Center at Mebane

Mebane, North Carolina, 27302, United States

Location

Annie Penn Memorial Hospital

Reidsville, North Carolina, 27320, United States

Location

Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, 27893, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103, United States

Location

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, 58401, United States

Location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431, United States

Location

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459, United States

Location

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

Location

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, 45236, United States

Location

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Dayton Physicians LLC-Samaritan North

Dayton, Ohio, 45415, United States

Location

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

Location

Armes Family Cancer Center

Findlay, Ohio, 45840, United States

Location

Blanchard Valley Hospital

Findlay, Ohio, 45840, United States

Location

Orion Cancer Care

Findlay, Ohio, 45840, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005, United States

Location

Dayton Physicians LLC-Wayne

Greenville, Ohio, 45331, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

Location

First Dayton Cancer Care

Kettering, Ohio, 45420, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Dayton Physicians LLC-Signal Point

Middletown, Ohio, 45042, United States

Location

Dayton Physicians LLC-Wilson

Sidney, Ohio, 45365, United States

Location

Springfield Regional Cancer Center

Springfield, Ohio, 45504, United States

Location

Springfield Regional Medical Center

Springfield, Ohio, 45505, United States

Location

Dayton Physicians LLC-Upper Valley

Troy, Ohio, 45373, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, 97814, United States

Location

Saint Charles Health System

Bend, Oregon, 97701, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Providence Oncology and Hematology Care Southeast

Clackamas, Oregon, 97015, United States

Location

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

Location

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, 97914, United States

Location

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

Location

Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Charleston Hematology Oncology Associates-Roper

Charleston, South Carolina, 29403, United States

Location

Lowcountry Hematology Oncology PA-North Charleston

Charleston, South Carolina, 29406, United States

Location

Bon Secours Saint Francis Hospital

Charleston, South Carolina, 29414, United States

Location

Charleston Hematology Oncology Associates PA-Saint Francis

Charleston, South Carolina, 29414, United States

Location

Lowcountry Hematology Oncology PA-West Ashley

Charleston, South Carolina, 29414, United States

Location

Greenville Health System Cancer Institute-Laurens

Clinton, South Carolina, 29325, United States

Location

Greenville Health System Cancer Institute-Easley

Easley, South Carolina, 29640, United States

Location

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29615, United States

Location

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, 29650, United States

Location

Lowcountry Hematology Oncology PA-Mount Pleasant

Mt. Pleasant, South Carolina, 29464, United States

Location

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Vanderbilt-Ingram Cancer Center Cool Springs

Franklin, Tennessee, 37067, United States

Location

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520, United States

Location

Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States

Location

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531, United States

Location

Swedish Medical Center-Edmonds

Edmonds, Washington, 98026, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503, United States

Location

PeaceHealth Saint John Medical Center

Longview, Washington, 98632, United States

Location

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107, United States

Location

Kaiser Permanente Washington

Seattle, Washington, 98112, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122-4307, United States

Location

Swedish Medical Center-Cherry Hill

Seattle, Washington, 98122-5711, United States

Location

Providence Regional Cancer System-Shelton

Shelton, Washington, 98584, United States

Location

Rockwood Cancer Treatment Center-DHEC-Downtown

Spokane, Washington, 99204, United States

Location

Rockwood North Cancer Treatment Center

Spokane, Washington, 99218, United States

Location

Rockwood Clinic Cancer Treatment Center-Valley

Spokane Valley, Washington, 99216, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362, United States

Location

Providence Regional Cancer System-Yelm

Yelm, Washington, 98597, United States

Location

United Hospital Center

Bridgeport, West Virginia, 26330, United States

Location

WVUH-Berkely Medical Center

Martinsburg, West Virginia, 25401, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

Camden Clark Medical Center

Parkersburg, West Virginia, 26101, United States

Location

Ashland Memorial Medical Center

Ashland, Wisconsin, 54806, United States

Location

Duluth Clinic Ashland

Ashland, Wisconsin, 54806, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Billings Clinic-Cody

Cody, Wyoming, 82414, United States

Location

Welch Cancer Center

Sheridan, Wyoming, 82801, United States

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Bevacizumab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Caroline Chung, MD
• Organization: MD Anderson Cancer Center

cchung3@mdanderson.org

(713) 745-5422

Study Officials

• Caroline Chung, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: April 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: December 15, 2022
• Last Updated: March 23, 2023
• Results First Posted: August 6, 2021

Record last verified: 2023-02

Locations

US (332); CA (9)