A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, ALLIANCE IND # 15380) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

Who is this study for? Patients with Glioblastoma, Gliosarcoma
What treatments are being studied? Bevacizumab
Status: Active, not recruiting
Location: See all (417) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Regional Hospital
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Arkansas
Mercy Cancer Center-Hot Springs
Hot Springs
University of Arkansas for Medical Sciences
Little Rock
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
Sutter Auburn Faith Hospital
Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Mills - Peninsula Hospitals
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Eden Hospital Medical Center
Castro Valley
Sutter Davis Hospital
Davis
Epic Care-Dublin
Dublin
Bay Area Breast Surgeons Inc
Emeryville
Epic Care Partners in Cancer Care
Emeryville
Kaiser Permanente-Fremont
Fremont
Fresno Cancer Center
Fresno
Kaiser Permanente
Fresno
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Contra Costa Regional Medical Center
Martinez
Kaiser Permanente-Modesto
Modesto
Memorial Medical Center
Modesto
Palo Alto Medical Foundation-Camino Division
Mountain View
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View
Alta Bates Summit Medical Center - Summit Campus
Oakland
Bay Area Tumor Institute
Oakland
Kaiser Permanente Oakland-Broadway
Oakland
Kaiser Permanente-Oakland
Oakland
Palo Alto Medical Foundation Health Care
Palo Alto
Stanford Cancer Institute
Palo Alto
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova
Kaiser Permanente-Redwood City
Redwood City
Kaiser Permanente-Richmond
Richmond
Rohnert Park Cancer Center
Rohnert Park
Kaiser Permanente-Roseville
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Roseville
Kaiser Permanente - Sacramento
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
South Sacramento Cancer Center
Sacramento
Sutter General Hospital
Sacramento
California Pacific Medical Center-Pacific Campus
San Francisco
Kaiser Permanente-San Francisco
San Francisco
UCSF Medical Center-Mount Zion
San Francisco
UCSF Medical Center-Parnassus
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
San Leandro
Kaiser Permanente-San Rafael
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Kaiser Permanente-Santa Rosa
Santa Rosa
Sutter Pacific Medical Foundation
Santa Rosa
Kaiser Permanente Cancer Treatment Center
South San Francisco
Kaiser Permanente-South San Francisco
South San Francisco
Kaiser Permanente-Stockton
Stockton
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Kaiser Permanente Medical Center-Vacaville
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
Kaiser Permanente-Vallejo
Vallejo
Sutter Solano Medical Center/Cancer Center
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
The Medical Center of Aurora
Aurora
Boulder Community Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
Colorado Blood Cancer Institute
Denver
Colorado Cancer Research Program NCORP
Denver
Porter Adventist Hospital
Denver
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Rose Medical Center
Denver
SCL Health Saint Joseph Hospital
Denver
Mercy Medical Center
Durango
Southwest Oncology PC
Durango
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood
Swedish Medical Center
Englewood
Mountain Blue Cancer Care Center
Golden
North Colorado Medical Center
Greeley
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Rocky Mountain Cancer Centers-Littleton
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Sky Ridge Medical Center
Lone Tree
Longmont United Hospital
Longmont
Rocky Mountain Cancer Centers-Longmont
Longmont
McKee Medical Center
Loveland
Parker Adventist Hospital
Parker
Rocky Mountain Cancer Centers-Parker
Parker
Rocky Mountain Cancer Centers - Pueblo
Pueblo
Saint Mary Corwin Medical Center
Pueblo
Rocky Mountain Cancer Centers-Thornton
Thornton
SCL Health Lutheran Medical Center
Wheat Ridge
Connecticut
Saint Vincent's Medical Center
Bridgeport
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Florida
Boca Raton Regional Hospital
Boca Raton
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Mount Sinai Medical Center
Miami Beach
Memorial Hospital West
Pembroke Pines
Georgia
Emory University Hospital Midtown
Atlanta
Emory University/Winship Cancer Institute
Atlanta
Piedmont Hospital
Atlanta
Iowa
Medical Oncology and Hematology Associates-West Des Moines
Clive
Mercy Cancer Center-West Lakes
Clive
Alegent Health Mercy Hospital
Council Bluffs
Greater Regional Medical Center
Creston
Medical Oncology and Hematology Associates-Laurel
Des Moines
Mercy Medical Center - Des Moines
Des Moines
Mercy Medical Center-West Lakes
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Mountain States Tumor Institute
Boise
Kootenai Medical Center
Coeur D'alene
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa
Kootenai Cancer Center
Post Falls
Kootenai Cancer Clinic
Sandpoint
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls
Illinois
Illinois CancerCare-Bloomington
Bloomington
Saint Joseph Medical Center
Bloomington
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
Northwestern University
Chicago
Rush University Medical Center
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
Cancer Care Center of Decatur
Decatur
Decatur Memorial Hospital
Decatur
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
NorthShore University HealthSystem-Evanston Hospital
Evanston
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Highland Park
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Illinois CancerCare-Ottawa Clinic
Ottawa
Radiation Oncology of Northern Illinois
Ottawa
Illinois CancerCare-Pekin
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Illinois CancerCare-Princeton
Princeton
Central Illinois Hematology Oncology Center
Springfield
Memorial Medical Center
Springfield
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Cancer Care Specialists of Illinois-Swansea
Swansea
Northwestern Medicine Cancer Center Warrenville
Warrenville
Indiana
Elkhart Clinic
Elkhart
Elkhart General Hospital
Elkhart
Michiana Hematology Oncology PC-Elkhart
Elkhart
Parkview Hospital Randallia
Fort Wayne
Radiation Oncology Associates PC
Fort Wayne
Franciscan Health Indianapolis
Indianapolis
Community Howard Regional Health
Kokomo
IU Health La Porte Hospital
La Porte
Memorial Regional Cancer Center Day Road
Mishawaka
Michiana Hematology Oncology PC-Mishawaka
Mishawaka
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka
Michiana Hematology Oncology PC-Plymouth
Plymouth
Reid Health
Richmond
Memorial Hospital of South Bend
South Bend
Michiana Hematology Oncology PC-South Bend
South Bend
Northern Indiana Cancer Research Consortium
South Bend
South Bend Clinic
South Bend
Michiana Hematology Oncology PC-Westville
Westville
Kansas
Kansas Institute of Medicine Cancer and Blood Center
Lenexa
Minimally Invasive Surgery Hospital
Lenexa
Menorah Medical Center
Overland Park
Saint Luke's South Hospital
Overland Park
Kansas City NCI Community Oncology Research Program
Prairie Village
Kentucky
Flaget Memorial Hospital
Bardstown
Commonwealth Cancer Center-Corbin
Corbin
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
University of Kentucky/Markey Cancer Center
Lexington
Jewish Hospital
Louisville
Jewish Hospital Medical Center Northeast
Louisville
Norton Hospital Pavilion and Medical Campus
Louisville
Saints Mary and Elizabeth Hospital
Louisville
Jewish Hospital Medical Center South
Shepherdsville
Massachusetts
Massachusetts General Hospital Cancer Center
Boston
Tufts Medical Center
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Sinai Hospital of Baltimore
Baltimore
University of Maryland/Greenebaum Cancer Center
Baltimore
Northwest Hospital Center
Randallstown
Maine
Maine Medical Center- Scarborough Campus
Scarborough
Michigan
Bixby Medical Center
Adrian
Hickman Cancer Center
Adrian
Michigan Cancer Research Consortium NCORP
Ann Arbor
Saint Joseph Mercy Hospital
Ann Arbor
Beaumont Hospital-Dearborn
Dearborn
Saint John Hospital and Medical Center
Detroit
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Allegiance Health
Jackson
Sparrow Hospital
Lansing
Saint Mary Mercy Hospital
Livonia
Marquette General Hematology Oncology
Marquette
Marquette General Hospital
Marquette
Mercy Memorial Hospital
Monroe
Toledo Clinic Cancer Centers-Monroe
Monroe
Saint Joseph Mercy Oakland
Pontiac
Saint Mary's of Michigan
Saginaw
Lakeland Hospital
Saint Joseph
Marie Yeager Cancer Center
Saint Joseph
Saint John Macomb-Oakland Hospital
Warren
Minnesota
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Essentia Health Cancer Center
Duluth
Essentia Health Saint Mary's Medical Center
Duluth
Miller-Dwan Hospital
Duluth
Fairview-Southdale Hospital
Edina
Unity Hospital
Fridley
Fairview Maple Grove Medical Center
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
New Ulm Medical Center
New Ulm
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic
Rochester
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Fairview Lakes Medical Center
Wyoming
Missouri
Parkland Health Center-Bonne Terre
Bonne Terre
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
Centerpoint Medical Center LLC
Independence
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City
Heartland Hematology and Oncology Associates Incorporated
Kansas City
North Kansas City Hospital
Kansas City
Research Medical Center
Kansas City
Saint Luke's Hospital of Kansas City
Kansas City
Saint Luke's East - Lee's Summit
Lee's Summit
Liberty Radiation Oncology Center
Liberty
Heartland Regional Medical Center
Saint Joseph
Saint Joseph Oncology Inc
Saint Joseph
Missouri Baptist Medical Center
Saint Louis
Washington University School of Medicine
Saint Louis
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Frontier Cancer Center and Blood Institute-Billings
Billings
Montana Cancer Consortium NCORP
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Saint Peter's Community Hospital
Helena
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
Montana Cancer Specialists
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Duke University Medical Center
Durham
East Carolina University
Greenville
Wake Forest University Health Sciences
Winston-salem
North Dakota
Altru Cancer Center
Grand Forks
Nebraska
CHI Health Saint Francis
Grand Island
CHI Health Good Samaritan
Kearney
Heartland Hematology and Oncology
Kearney
Nebraska Cancer Research Center
Lincoln
Saint Elizabeth Regional Medical Center
Lincoln
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Hemotology and Oncology Consultants PC
Omaha
Missouri Valley Cancer Consortium
Omaha
University of Nebraska Medical Center
Omaha
Midlands Community Hospital
Papillion
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Hackensack University Medical Center
Hackensack
Rutgers Cancer Institute of New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
The Valley Hospital-Luckow Pavilion
Paramus
Neurosurgeons of New Jersey-Ridgewood
Ridgewood
Valley Hospital
Ridgewood
Valley Health System-Hematology/Oncology
Westwood
New York
Columbia University/Herbert Irving Cancer Center
New York
University of Rochester
Rochester
Ohio
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
TriHealth Cancer Institute-Anderson
Cincinnati
TriHealth Cancer Institute-Westside
Cincinnati
University of Cincinnati/Barrett Cancer Center
Cincinnati
Case Western Reserve University
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Good Samaritan Hospital - Dayton
Dayton
Grandview Hospital
Dayton
Miami Valley Hospital
Dayton
Samaritan North Health Center
Dayton
Blanchard Valley Hospital
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Wayne Hospital
Greenville
Kettering Medical Center
Kettering
Lima Memorial Hospital
Lima
Toledo Clinic Cancer Centers-Maumee
Maumee
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee
Saint Charles Hospital
Oregon
Toledo Clinic Cancer Centers-Oregon
Oregon
Flower Hospital
Sylvania
Mercy Hospital of Tiffin
Tiffin
Mercy Saint Anne Hospital
Toledo
Saint Vincent Mercy Medical Center
Toledo
The Toledo Hospital/Toledo Children's Hospital
Toledo
Toledo Clinic Cancer Centers-Toledo
Toledo
University of Toledo
Toledo
Upper Valley Medical Center
Troy
Fulton County Health Center
Wauseon
University Pointe
West Chester
Greene Memorial Hospital
Xenia
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Oncology and Hematology Care Southeast
Clackamas
Bay Area Hospital
Coos Bay
Legacy Mount Hood Medical Center
Gresham
Providence Milwaukie Hospital
Milwaukie
Providence Newberg Medical Center
Newberg
Providence Willamette Falls Medical Center
Oregon City
Legacy Good Samaritan Hospital and Medical Center
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Legacy Meridian Park Hospital
Tualatin
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
South Dakota
Avera Cancer Institute
Sioux Falls
Tennessee
Memorial Hospital
Chattanooga
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson
Memorial GYN Plus
Ooltewah
Texas
Saint Joseph Regional Cancer Center
Bryan
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
Virginia
Inova Fairfax Hospital
Falls Church
Fredericksburg Oncology Inc
Fredericksburg
Sentara Norfolk General Hospital
Norfolk
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
Cancer Care Center at Island Hospital
Anacortes
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton
Harrison Medical Center
Bremerton
Highline Medical Center-Main Campus
Burien
Providence Regional Cancer System-Centralia
Centralia
Swedish Medical Center-Edmonds
Edmonds
Saint Elizabeth Hospital
Enumclaw
Providence Regional Cancer Partnership
Everett
Saint Francis Hospital
Federal Way
Swedish Cancer Institute-Issaquah
Issaquah
Providence Regional Cancer System-Lacey
Lacey
Saint Clare Hospital
Lakewood
PeaceHealth Saint John Medical Center
Longview
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
Group Health Cooperative-Seattle
Seattle
Minor and James Medical PLLC
Seattle
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-First Hill
Seattle
Providence Regional Cancer System-Shelton
Shelton
Evergreen Hematology and Oncology PS
Spokane
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley
Franciscan Research Center-Northwest Medical Plaza
Tacoma
Northwest Medical Specialties PLLC
Tacoma
Compass Oncology Vancouver
Vancouver
Legacy Salmon Creek Hospital
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
University of Wisconsin Hospital and Clinics
Madison
Aurora Saint Luke's Medical Center
Milwaukee
Cancer Center of Western Wisconsin
New Richmond
Aurora Cancer Care-Racine
Racine
Wyoming
Cheyenne Regional Medical Center-West
Cheyenne
Big Horn Basin Cancer Center
Cody
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Time Frame
Start Date: May 2013
Estimated Completion Date: April 3, 2017
Participants
Target number of participants: 90
Treatments
Experimental: Arm 1, HSPPC-96 + concomitant bevacizumab
HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days)~Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression.
Experimental: Arm 2, HSPPC-96 with bevacizumab at progression
HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days)~NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab.~Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine.
Active Comparator: Arm 3, Bevacizumab
Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days)
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: Agenus Inc., National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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