Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme

April 24, 2018 updated by: National Cancer Institute (NCI)

Phase I/Comparative Randomized Phase II Trial of TRC105 Plus Bevacizumab Versus Bevacizumab in Bevacizumab-Naive Patients With Recurrent Glioblastoma Multiforme

This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To establish a maximum tolerated dose (MTD) of TRC105 (anti-endoglin monoclonal antibody TRC105) combined with bevacizumab in this patient population. (Phase I) II. To assess the safety and adverse events of TRC105 in combination with bevacizumab in this patient population. (Phase II) III. To determine the efficacy of TRC105 in combination with bevacizumab in recurrent glioblastoma as measured by progression-free survival and compare it with the efficacy of bevacizumab alone in this patient population. (Phase II)

SECONDARY OBJECTIVES:

I. To assess the proportion of patients, who are progression free at 6 months, treated with TRC105 in combination with bevacizumab as compared to bevacizumab alone. (Phase II) II. To assess the overall survival of patients treated with TRC105 in combination with bevacizumab compared to bevacizumab alone. (Phase II) III. To compare the impact of the treatment on the patients quality of life (QOL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)-C15-Palliative Care (PAL) and QLQ-brain neoplasm (BN)20 Patient Questionnaires. (Phase II) IV. To estimate patient recommendations for study participation to others using the Was It Worth It (WIWI) Questionnaire. (Phase II)

TERTIARY OBJECTIVES:

I. To evaluate the pharmacokinetics of TRC105. (Phase I) II. To evaluate the immunogenicity of TRC105. (Phase I) III. To determine the relationship between tumor biomarkers, circulating biomarkers of vascular response and vascular endothelial growth factor (VEGF)/VEGF receptor (VEGFR) single-nucleotide polymorphisms (SNPs) in predicting efficacy and/or toxicity of treatment. (Phase II) IV. To assess the utility of magnetic resonance imaging (MRI) imaging including apparent diffusion coefficient (ADC) as a predictor of response and survival. (Phase II) V. To assess the utility of dynamic contrast enhanced (DCE) MRI as a predictor of response to bevacizumab with or without TRC105. (Phase II)

OUTLINE: This is a phase I dose-escalation study of anti-endoglin monoclonal antibody TRC105, followed by a randomized phase II study.

Phase I (closed to accrual 1/14/14): Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Phase II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Fullerton, California, United States, 92835
        • Saint Jude Medical Center
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94115
        • UCSF Medical Center-Mount Zion
      • San Francisco, California, United States, 94143
        • UCSF Medical Center-Parnassus
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Greenwich Hospital
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital/Bennett Cancer Center
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
      • Newark, Delaware, United States, 19713
        • Christiana Gynecologic Oncology LLC
      • Newark, Delaware, United States, 19713
        • Regional Hematology and Oncology PA
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
      • Seaford, Delaware, United States, 19973
        • Nanticoke Memorial Hospital
      • Wilmington, Delaware, United States, 19801
        • Christiana Care Health System-Wilmington Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Medical Center
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Cancer Clinic
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, United States, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Center of Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Highland Park, Illinois, United States, 60035
        • Hematology Oncology Associates of Illinois-Highland Park
      • Kankakee, Illinois, United States, 60901
        • Presence Saint Mary's Hospital
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, United States, 60048
        • NorthShore Hematology Oncology-Libertyville
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Moline, Illinois, United States, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Spector, David MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Trinity Medical Center
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists-Niles
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, United States, 61350
        • Radiation Oncology of Northern Illinois
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, United States, 61554
        • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Skokie, Illinois, United States, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62702
        • Central Illinois Hematology Oncology Center
      • Swansea, Illinois, United States, 62226
        • Cancer Care Specialists of Illinois-Swansea
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Michiana Hematology Oncology PC-Crown Point
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, United States, 46514-2098
        • Elkhart Clinic
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Kokomo, Indiana, United States, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, United States, 46350
        • IU Health La Porte Hospital
      • Mishawaka, Indiana, United States, 46544
        • Memorial Regional Cancer Center Day Road
      • Mishawaka, Indiana, United States, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, United States, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • Richmond, Indiana, United States, 47374
        • Reid Health
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • Michiana Hematology Oncology PC-South Bend
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Bettendorf, Iowa, United States, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Boone, Iowa, United States, 50036
        • McFarland Clinic PC-Boone
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Fort Dodge, Iowa, United States, 50501
        • McFarland Clinic PC-Trinity Cancer Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, United States, 50129
        • McFarland Clinic PC-Jefferson
      • Marshalltown, Iowa, United States, 50158
        • McFarland Clinic PC-Marshalltown
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas-Liberal
      • Manhattan, Kansas, United States, 66502
        • Cancer Center of Kansas-Manhattan
      • McPherson, Kansas, United States, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Wichita NCI Community Oncology Research Program
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Corbin, Kentucky, United States, 40701
        • Baptist Health Corbin
      • Crestview Hills, Kentucky, United States, 41017
        • Oncology Hematology Care Inc-Crestview
      • Elizabethtown, Kentucky, United States, 42701
        • Hardin Memorial Hospital
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Madisonville, Kentucky, United States, 42431
        • Baptist Health Madisonville/Merle Mahr Cancer Center
      • Paducah, Kentucky, United States, 42003
        • Baptist Health Paducah
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
      • Brewer, Maine, United States, 04412
        • Lafayette Family Cancer Center-EMMC
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine-Scarborough
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Medical Center
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Hospital
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Dearborn, Michigan, United States, 48124
        • Beaumont Hospital-Dearborn
      • Detroit, Michigan, United States, 48236
        • Saint John Hospital and Medical Center
      • Flint, Michigan, United States, 48502
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, United States, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Mercy Campus
      • Niles, Michigan, United States, 49120
        • Lakeland Community Hospital
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Lake Huron Medical Center
      • Reed City, Michigan, United States, 49677
        • Spectrum Health Reed City Hospital
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Ann Arbor Hematology -Oncology Associates
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Saint Luke's Hospital of Duluth
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, United States, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Bonne Terre, Missouri, United States, 63628
        • Parkland Health Center-Bonne Terre
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Jefferson City, Missouri, United States, 65109
        • Capital Region Medical Center-Goldschmidt Cancer Center
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • Missouri Baptist Outpatient Center-Sunset Hills
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59101
        • Montana Cancer Consortium NCORP
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Missoula, Montana, United States, 59804
        • Community Medical Hospital
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology Hematology PA-Hooksett
      • Laconia, New Hampshire, United States, 03246
        • LRGHealthcare-Lakes Region General Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Voorhees, New Jersey, United States, 08043
        • MD Anderson Cancer Center at Cooper-Voorhees
    • New York
      • Auburn, New York, United States, 13021
        • Hematology Oncology Associates of Central New York-Auburn
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, United States, 13215
        • Hematology Oncology Associates of Central New York-Onondaga Hill
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists PA
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Bowling Green, Ohio, United States, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care Inc-Blue Ash
      • Cincinnati, Ohio, United States, 45202
        • Oncology Hematology Care Inc-Eden Park
      • Cincinnati, Ohio, United States, 45211
        • Oncology Hematology Care Inc-Mercy West
      • Cincinnati, Ohio, United States, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, United States, 45230
        • Oncology Hematology Care Inc - Anderson
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, United States, 43215
        • Columbus NCI Community Oncology Research Program
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Health Center
      • Delaware, Ohio, United States, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, United States, 43015
        • Delaware Radiation Oncology
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Fairfield, Ohio, United States, 45014
        • Oncology Hematology Care Inc-Healthplex
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, United States, 43302
        • OneHealth Marion General Hospital
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, United States, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Newark Radiation Oncology
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, United States, 45505
        • Springfield Regional Medical Center
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, United States, 43623
        • Mercy Saint Anne Hospital
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Harrisburg, Pennsylvania, United States, 17109
        • PinnacleHealth Cancer Center-Community Campus
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • Greenville Health System Cancer Institute-Easley
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Andrews
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Butternut
      • Greer, South Carolina, United States, 29650
        • Greenville Health System Cancer Institute-Greer
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, United States, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
    • Texas
      • Austin, Texas, United States, 78701
        • University Medical Center Brackenridge
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology Inc
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Menomonee Falls, Wisconsin, United States, 53051
        • Community Memorial Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and The Medical College of Wisconsin
      • Mukwonago, Wisconsin, United States, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Waukesha Memorial Hospital
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Cody, Wyoming, United States, 82414
        • Big Horn Basin Cancer Center
      • Cody, Wyoming, United States, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological confirmation of grade 3 or 4 glioma, including astrocytoma, oligodendroglioma, and mixed gliomas, as determined by pre-registration central pathology review (Phase I)
  • Histological confirmation of glioblastoma multiforme (grade 4 astrocytoma) as determined by pre-registration central pathology review; note: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) are eligible; glioblastoma (GBM) with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q co-deleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q co-deletion status (Phase II)
  • Evidence of tumor progression by MRI or computed tomography (CT) scan following radiation therapy or following the most recent anti-tumor therapy; note: patients who have had surgical treatment at recurrence are eligible if they had a resection with measurable or non-measurable residual disease on postoperative imaging or if there is imaging evidence of disease progression as compared to the first postoperative scan
  • Measurable or evaluable disease by gadolinium MRI or contrast CT scan; note: patients who have had a gross total resection (GTR) are eligible on the basis of evaluable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • White blood cells (WBC) >= 3,000/mL
  • Hemoglobin >= 10.0 g/dL; note: this level may be reached by transfusion
  • Total bilirubin =< institutional upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x ULN
  • Creatinine =< ULN
  • Life expectancy >= 12 weeks
  • Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Urine protein creatinine (UPC) ratio < 1; note: urine protein must be screened by urine analysis for UPC ratio; for UPC ratio >= 1.0, 24-hour urine protein must be obtained and the level should be < 1,000 mg for registration
  • Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
  • Calculated glomerular filtration rate (GFR) must be >= 60 ml/min; GFR will be calculated as needed per institutional guidelines
  • Any number of prior chemotherapy regimens for recurrent disease (Phase I); =< 1 chemotherapy or other non-antiangiogenic regimen for recurrent disease (Phase II)
  • Last dose of bevacizumab >= 2 weeks prior to registration (Phase I); note: for the phase II study only, prior exposure to bevacizumab is not allowed
  • Surgery >= 4 weeks prior to registration
  • Completion of radiation therapy >= 12 weeks prior to registration and prior chemotherapy >= 4 weeks prior to registration (>= 6 weeks from nitrosourea-containing regimens)
  • Small molecular cell cycle inhibitors >= 2 weeks from registration
  • Ability to provide informed written consent
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Willing to return to enrolling institution for follow-up
  • Willing to discontinue use of medications that inhibit platelet function >= 10 days prior to registration; aspirin at doses greater than 325 mg/day must be discontinued >= 10 days prior to registration and avoided through the study; note: nonsteroidal anti-inflammatory drug (NSAID) medications are recommended in place of aspirin; if NSAIDs or aspirin are used, histamine (H)-2 blockers and proton pump inhibitor (PPI) medications are recommended
  • Willing to provide mandatory blood and tissue samples for correlative research purposes (Phase I and II)

Exclusion Criteria:

  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for at least 6 months after treatment has ended
  • Prior hypersensitivity to bevacizumab or toxicity requiring discontinuation of bevacizumab (Phase I)
  • Any prior exposure to any VEGF or VEGF inhibitor including, but not limited to, bevacizumab, cediranib, vandetanib, sunitinib, pazopanib, aflibercept, or sorafenib (Phase II)
  • Prior hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (Phase I and II)
  • Prior hypersensitivity to triptan derivatives (Phase I and II)
  • Other active malignancy =< 3 years prior to registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • Uncontrolled infection
  • Immunocompromised patients or patients known to be human immunodeficiency virus (HIV) positive and currently receiving combination antiretroviral therapy; patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
  • History of hypertensive crisis or hypertensive encephalopathy

  • Clinically significant cardiovascular disease defined as follows:

    • Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] > 160 mm Hg and/or diastolic blood pressure [DBP] > 90 mm Hg despite antihypertensive therapy)
    • History of cerebrovascular accident (CVA) within 6 months
    • Myocardial infarction or unstable angina within 6 months
    • New York Heart Association classification II, III, or IV cardiovascular disease
    • Serious and inadequately controlled cardiac arrhythmia
    • Significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)
    • Clinically significant peripheral vascular disease
  • Evidence or history of bleeding diathesis (greater than normal risk of bleeding, i.e., hereditary hemorrhagic telangiectasia type I or HHT-1) or coagulopathy in the absence of therapeutic anti-coagulation or any hemorrhage/bleeding event > grade 3 within 4 weeks prior to registration; note: patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose for at least 2 weeks of low molecular weight heparin; therapeutic Coumadin and aspirin doses > 325 mg daily are not allowed
  • Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm
  • Prior treatment with TRC105
  • Serious or non-healing wound, active ulcer, or untreated bone fracture
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration

  • History of invasive procedures defined as follows:

    • Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days prior to registration
    • Anticipation of need for major surgical procedures during the study
    • Core biopsy =< 7 days prior to registration
  • History of significant vascular disease (i.e., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to registration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (bevacizumab and TRC105)
Patients receive bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Pharmacological Study
Correlative studies
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar FKB238
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
Biological: Anti-Endoglin Chimeric Monoclonal Antibody TRC105
Given IV
Other Names:
  • TRC105
Active Comparator: Arm II (bevacizumab)
Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Pharmacological Study
Correlative studies
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar FKB238
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) (Phase I) as Measured by the Number of Participants With Dose Limiting Toxicities
Time Frame: 28 days
MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience dose-limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of DLT's will be reported here.
28 days
Progression-free Survival (PFS) (Phase II)
Time Frame: The time from study randomization to documentation of disease progression, assessed up to 2 years
Progression Free Survival time is defined as the time from study randomization to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. The time-to-progression distribution will be estimated using the Kaplan-Meier method.
The time from study randomization to documentation of disease progression, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Toxicity Rate for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment (Phase II)
Time Frame: Up to 2 years
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. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment will be compared using a Fisher's Exact test between the 2 treatment groups.
Up to 2 years
Overall Survival (Phase II)
Time Frame: The time from start of study therapy to death due to any cause, assessed up to 2 years
Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both groups of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.
The time from start of study therapy to death due to any cause, assessed up to 2 years
Progression Free Survival at 6 Months (PFS6) (Phase II) as Measured by the Percentage of Participants With Progression Free Survival at 6 Months
Time Frame: The time from study randomization to documentation of disease progression, assessed at 6 months
PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause (whichever comes first). The medians and confidence intervals given are the Kaplan-Meier estimates.
The time from study randomization to documentation of disease progression, assessed at 6 months
Quality of Life (QOL) as Assessed by the EORTC QLQ-C15-PAL Questionnaire [Item 15: Global Health Status/Quality of Life] (Phase II)
Time Frame: Baseline and 4 weeks
Quality of Life (QOL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire, as measured by the change from baseline to the end of cycle 2 (4 weeks) in the EORTC QLQ-C15-PAL item 15, Global health status/quality of life, score. The assessment was scored using EORTC's scoring algorithms. The score range is from 0-100 (0 corresponding to worst outcome; 100 corresponding to best outcome). Range of the change in scores from baseline to cycle 2 (4 weeks) is (-100,100). The mean change in score and 95% confidence interval of the change from baseline to the end of cycle 2 (4 weeks) are reported below.
Baseline and 4 weeks
QOL Assessed by EORTC-QLQ-BN20 Patient Questionnaire [Items 1-20] (Phase II)
Time Frame: Baseline and 4 weeks
QOL assessed by EORTC-QLQ-BN20 Patient Questionnaire (Brain cancer module), as measured by the change from baseline to the end of cycle 2 (4 weeks) in the EORTC QLQ-BN20 Items 1-20 are used to score the following 11 symptom scales: Future uncertainty (Items 1-3,5), Visual disorder (Items 6-8), Motor dysfunction (Items 10,15, 19), Communication deficit (Items 11-13), Headaches (Item 4), Seizures (Item 9), Drowsiness (Item 14), Itchy Skin (Item 17), Hair Loss (Item 16), Weakness of legs (Item 18), and Bladder control (Item 20). The assessment was scored using EORTC's scoring algorithms. The score range for each of the 11 symptom scales is from 0-100 (0 corresponding to not severe;100 corresponding to most severe). Range of changes in scores from baseline to cycle 2 (4 weeks) is (-100,100). The mean change in score and 95% confidence interval of each symptom scale are reported below.
Baseline and 4 weeks
QOL Assessed by WIWI Questionnaire (Phase II)
Time Frame: Up to 4 weeks
Quality of life (QOL) assessed by Was it worth it? (WIWI) questionnaire, as measured by the percentage of patients answering yes to the question "Was it worthwhile for you to participate in this research study?"
Up to 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DCE-MRI Utility
Time Frame: Baseline to up to 2 years
Associations between the change of DCE-MRI and PFS6 will be assessed using two-sample t-test.
Baseline to up to 2 years
Change in MRI ADC Utility
Time Frame: Baseline to up to 2 years
MRI ADC histogram metrics such as overall ADC, mean ADC of lower curve, percentage of ADC in lower curve, and skewness at baseline and change from baseline to the first follow-up MRI will be analyzed for association with progression free and overall survival. Kaplan-Meier survival curves, logrank and Cox regression tests will be used to estimate and compare the equality of the overall survival and progression-time distributions of patient subsets defined by the ADC histogram metrics.
Baseline to up to 2 years
Changes in Tumor and Circulating Biomarkers
Time Frame: Baseline to up to 2 years
Binary endpoints and categorical endpoints will be compared using Chi-Squared or Fisher's Exact tests between treatment groups. Continuous endpoints will be analyzed using change-from-baseline measures and compared using t-tests between treatment groups and time-points. Cox proportional hazards regression will be used to determine if there are differences in PFS and OS between the treatment groups after correcting for each biomarker in conjunction with standard clinical variables.
Baseline to up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 11, 2016

Study Completion (Actual)

April 15, 2017

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01989 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (U.S. NIH Grant/Contract)
  • U10CA025224 (U.S. NIH Grant/Contract)
  • CDR0000737109
  • N1174 (Other Identifier: CTEP)
  • NCCTG-N1174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adult Anaplastic Astrocytoma

Clinical Trials on Laboratory Biomarker Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe