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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01814813
Other study ID # A071101
Secondary ID U10CA031946NCI-2
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 2013
Est. completion date May 1, 2023

Study information

Verified date May 2023
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.


Description:

The purpose of this study is to compare the effects of a vaccine with bevacizumab versus bevacizumab alone on a patient's brain tumor. The vaccine is called heat shock protein peptide complex 96 (HSPPC-96). HSPPC-96 is experimental. Specifically, HSPPC-96 is a protein that may work to help the body have a response against remaining brain tumor cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back. In this study, patients will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if the tumor comes back, or bevacizumab alone. The use of HSPPC-96 and bevacizumab is investigational. The primary objective of the study is to determine whether there is an overall survival advantage of HSPPC-96 administered with bevacizumab, given concomitantly or at the point of progression, in comparison with bevacizumab alone in patients with surgically resectable recurrent glioblastoma multiforme. The secondary objectives are: 1. to evaluate the safety and tolerability of HSPPC-96 with bevacizumab 2. to evaluate the progression free survival of HSPPC-96 with bevacizumab, given concomitantly or at the point of progression. Patients must undergo surgery within 28 days from pre-registration. There must be confirmation of adequacy of tissue for vaccine manufacture, tumor tissue submitted to Agenus, confirmation of ≥ 90% resection by central radiology review and vaccine manufacture of at least six vials. Patients will be randomized to one of three treatment arms. Please see the "Arms" section for more details. Patients will be monitored approximately 5 years post-surgery.


Recruitment information / eligibility

Status Terminated
Enrollment 90
Est. completion date May 1, 2023
Est. primary completion date April 3, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Pre-registration (Pre-Surgery) Eligibility Criteria - Histologic documentation: Prior histologic diagnosis of GBM at first occurrence - Stage: First or second recurrence of GBM or gliosarcoma considered to be surgically resectable - Prior Treatment: - No radiotherapy within 90 days prior to pre-registration - No prior treatment with any anti-angiogenic agent targeting the VEGF pathway including but not limited to bevacizumab, cediranib, vandetanib, sunitinib, pazopanib, aflibercept, or sorafenib - No prior treatment with HSPPC-96 or other investigational immunotherapy - Must have received prior treatment with radiotherapy and temozolomide for histologically confirmed GBM at initial diagnosis - No tumor directed therapy for most recent progression - No prior Gliadel® wafers - No clinically significant cardiovascular disease: - Patients with a history of hypertension must be well controlled (<150/90) on a regimen of antihypertensive therapy. - History of arterial thrombotic events within the past 6 months, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medial intervention in the past 6 months, or myocardial infarction (MI). Patients with clinically significant peripheral artery disease (i.e., claudication on less than one block), significant vascular disease (i.e., aortic aneurysm, history of aortic dissection) are not eligible. - 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 - No current New York Heart Association classification II, III or IV congestive heart failure - No significant bleeding within the past 6 months; no bleeding diathesis or coagulopathy - No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 12 months - No evidence of any systemic autoimmune disease (e.g. Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason - Age = 18 years of age - Karnofsky functional status rating =70 - No more than 16 mg dexamethasone (or equivalent) per day - Non-pregnant and non-nursing Registration (Post-Surgery) Eligibility Criteria - Pre-registration eligibility criteria continue to be met - Histologic documentation: confirmed histological diagnosis of recurrent GBM or gliosarcoma - = 90% surgical resection of recurrent GBM confirmed by central radiology review by MRI with or without gadolinium per institutional guidelines. A CT scan is allowable in place of MRI only in situations where an MRI is contraindicated (e.g., patient has a heart pacemaker, metallic devices in the eye, brain or spine, severe claustrophobia). - = 7 grams of resected tumor available for vaccine manufacture as determined by institutional pathologist - Availability of = 6 clinical vials of HSPPC-96 - Required Initial Laboratory Values: - Granulocytes =1,500/µL - Platelet count =100,000/µL - Total Bilirubin = 2.0 x ULN - UPC ratio <1 or Urine protein = 1+ - Calculated creatinine clearance = 45 ml/min - SGOT/SGPT(AST/ALT) = 2.5 x ULN - No serious, non-healing wounds or ulcers - At least 7 days since any minor surgery such as port placement - No major surgical procedures, open biopsy or significant traumatic injury = 28 days prior to registration or anticipation of need for elective or planned major surgical procedure during the study. Core biopsy or other minor surgical procedures =7 days prior to registration. - No active or recent hemoptysis (=½ teaspoon of bright red blood per episode) = 30 days prior to registration - No new bleeding on D28 (+/-3) MRI (or CT if MRI is contraindicated) - No clinical deterioration at the time of registration/randomization - If a second surgery is needed for completion of resection, this should be within 30 days from the first surgery

Study Design


Intervention

Biological:
HSPPC-96
intradermal infusion
Drug:
bevacizumab
intravenous

Locations

Country Name City State
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Cancer Care Center at Island Hospital Anacortes Washington
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Regional Hospital Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University/Winship Cancer Institute Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Sutter Auburn Faith Hospital Auburn California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States The Medical Center of Aurora Aurora Colorado
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Flaget Memorial Hospital Bardstown Kentucky
United States Swedish Cancer Institute-Eastside Oncology Hematology Bellevue Washington
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States Frontier Cancer Center and Blood Institute-Billings Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Boca Raton Regional Hospital Boca Raton Florida
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States Saint Vincent's Medical Center Bridgeport Connecticut
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Mills - Peninsula Hospitals Burlingame California
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Eden Hospital Medical Center Castro Valley California
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Memorial Hospital Chattanooga Tennessee
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States University of Cincinnati/Barrett Cancer Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Oncology and Hematology Care Southeast Clackamas Oregon
United States Case Western Reserve University Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Medical Center Coeur d'Alene Idaho
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Sutter Davis Hospital Davis California
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Samaritan North Health Center Dayton Ohio
United States Beaumont Hospital-Dearborn Dearborn Michigan
United States Cancer Care Center of Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Colorado Blood Cancer Institute Denver Colorado
United States Colorado Cancer Research Program NCORP Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Epic Care-Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Duke University Medical Center Durham North Carolina
United States Fairview-Southdale Hospital Edina Minnesota
United States Swedish Medical Center-Edmonds Edmonds Washington
United States Crossroads Cancer Center Effingham Illinois
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Comprehensive Cancer Care and Research Institute of Colorado LLC Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Inova Fairfax Hospital Falls Church Virginia
United States Saint Francis Hospital Federal Way Washington
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Parkview Hospital Randallia Fort Wayne Indiana
United States Radiation Oncology Associates PC Fort Wayne Indiana
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Kaiser Permanente-Fremont Fremont California
United States Fresno Cancer Center Fresno California
United States Kaiser Permanente Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Mountain Blue Cancer Care Center Golden Colorado
United States Altru Cancer Center Grand Forks North Dakota
United States CHI Health Saint Francis Grand Island Nebraska
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States East Carolina University Greenville North Carolina
United States Wayne Hospital Greenville Ohio
United States Rocky Mountain Cancer Centers-Greenwood Village Greenwood Village Colorado
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Hackensack University Medical Center Hackensack New Jersey
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Saint Peter's Community Hospital Helena Montana
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Mercy Cancer Center-Hot Springs Hot Springs Arkansas
United States Centerpoint Medical Center LLC Independence Missouri
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Heartland Hematology and Oncology Kearney Nebraska
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Community Howard Regional Health Kokomo Indiana
United States IU Health La Porte Hospital La Porte Indiana
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Sparrow Hospital Lansing Michigan
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Liberty Radiation Oncology Center Liberty Missouri
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Saint Mary Mercy Hospital Livonia Michigan
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States Jewish Hospital Medical Center Northeast Louisville Kentucky
United States Norton Hospital Pavilion and Medical Campus Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Fairview Maple Grove Medical Center Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marquette General Hematology Oncology Marquette Michigan
United States Marquette General Hospital Marquette Michigan
United States Contra Costa Regional Medical Center Martinez California
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Memorial Regional Cancer Center Day Road Mishawaka Indiana
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Saint Luke's Mountain States Tumor Institute - Nampa Nampa Idaho
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Columbia University/Herbert Irving Cancer Center New York New York
United States Providence Newberg Medical Center Newberg Oregon
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Kaiser Permanente Oakland-Broadway Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Hemotology and Oncology Consultants PC Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Memorial GYN Plus Ooltewah Tennessee
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto California
United States Midlands Community Hospital Papillion Nebraska
United States The Valley Hospital-Luckow Pavilion Paramus New Jersey
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Memorial Hospital West Pembroke Pines Florida
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Kootenai Cancer Center Post Falls Idaho
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Kansas City NCI Community Oncology Research Program Prairie Village Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Northwest Hospital Center Randallstown Maryland
United States Kaiser Permanente-Redwood City Redwood City California
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Neurosurgeons of New Jersey-Ridgewood Ridgewood New Jersey
United States Valley Hospital Ridgewood New Jersey
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States Rohnert Park Cancer Center Rohnert Park California
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States South Sacramento Cancer Center Sacramento California
United States Sutter General Hospital Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Hospital Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States UCSF Medical Center-Mount Zion San Francisco California
United States UCSF Medical Center-Parnassus San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Rafael San Rafael California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Group Health Cooperative-Seattle Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Avera Cancer Institute Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Evergreen Hematology and Oncology PS Spokane Washington
United States Rockwood Cancer Treatment Center-DHEC-Downtown Spokane Washington
United States Rockwood Clinic Cancer Treatment Center-Valley Spokane Valley Washington
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States Memorial Medical Center Springfield Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Cancer Care Specialists of Illinois-Swansea Swansea Illinois
United States Flower Hospital Sylvania Ohio
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States University of Toledo Toledo Ohio
United States Upper Valley Medical Center Troy Ohio
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Compass Oncology Vancouver Vancouver Washington
United States Legacy Salmon Creek Hospital Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Fulton County Health Center Wauseon Ohio
United States University Pointe West Chester Ohio
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States Valley Health System-Hematology/Oncology Westwood New Jersey
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Rice Memorial Hospital Willmar Minnesota
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Greene Memorial Hospital Xenia Ohio
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Providence Regional Cancer System-Yelm Yelm Washington

Sponsors (3)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology Agenus Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) The primary endpoint is overall survival (OS), which is defined as the date from study> registration to the date of death, due to any cause. Up to 5 years post-surgery
Secondary Progression Free Survival (PFS) Time to progression free survival: which is defined as the date from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). Progressive disease is defined as one or more of the following:New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids, increase by > 50% enhancement from the first post-surgical scan, or a subsequent scan with smaller tumor size, and the scan 8 weeks or later on stable or increasing doses of corticosteroids, clinical deterioration not attributable to concurrent medication or comorbid conditions is sufficient to declare progression on current treatment, for patients receiving bevacizumab therapy, significant increase in T2/FLAIR non-enhancing lesion. Up to 5 years post-surgery
Secondary Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5) The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. Up to 3 years
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