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An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component

Thank you

Trial Information

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma


The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug
temozolomide can help improve the life expectancy of patients with newly diagnosed, resected
EGFRvIII positive glioblastoma.

The duration of participation in this study may be up to 5 years. After you are screened and
enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF
or KLH until either disease progression or intolerance to the medications. If your tumor
progresses while on this study, your doctor may treat you with other therapies that are not
part of the study.


Inclusion Criteria:



Among other criteria, patients must meet the following conditions to be eligible for the
study:

1. Adult patients, ≥ 18 years old

2. Newly diagnosed glioblastoma

3. Attempted surgical resection followed by conventional chemoradiation

4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory

5. No evidence of progressive disease from the post-operative period to the
post-chemoradiation period

6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy

7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for
at least 3 days prior to randomization

8. WHO-ECOG Performance Status ≤ 2

9. Patients of childbearing/reproductive potential will be instructed to use birth
control as defined by your doctor.

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the
study:

1. Stereotactic biopsy only (without further surgical resection)

2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial
disease.

3. History, presence, or suspicion of metastatic disease

4. Patients who have received any additional treatment for glioblastoma, aside from
surgical resection and chemoradiation with temozolomide

5. Active systemic infection requiring treatment

6. History of any malignancy (other than glioblastoma) during the last three years
except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder
cancer or cured, early-stage prostate cancer in a patient with PSA level less than
the upper limit of normal

7. Planned major surgery

8. Evidence of current drug or alcohol abuse

9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF
(sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of
anaphylactic reactions to shellfish proteins

10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that could increase the risk associated with participating in a clinical trial

11. Women who are pregnant of lactating

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.

Outcome Time Frame:

During treatment and every three months from end of treatment through end of study or approximately up to 5 years.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CDX110-04

NCT ID:

NCT01480479

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Glioblastoma
  • Small Cell Glioblastoma
  • Giant Cell Glioblastoma
  • Gliosarcoma
  • Glioblastoma With Oligodendroglial Component
  • EGFRvIII
  • Glioblastoma
  • Small cell
  • Giant cell
  • Gliosarcoma
  • oligodendroglial
  • Brain Cancer
  • Brain Tumor
  • radiotherapy
  • chemoradiation
  • Tumor
  • temozolomide
  • EGFR variant III
  • Glioblastoma
  • Gliosarcoma

Name

Location

Cleveland Clinic Foundation Cleveland, Ohio  44195
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Washington University School of Medicine Saint Louis, Missouri  63110
University of Washington Medical Center Seattle, Washington  98195-6043
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Loyola University Medical Center Maywood, Illinois  60153
Fletcher Allen Health Care Burlington, Vermont  05401
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
New York Methodist Hospital Brooklyn, New York  11215-3609
North Shore University Hospital Manhasset, New York  11030
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Rochester Medical Center Rochester, New York  14642
Hartford Hospital Hartford, Connecticut  06102-5037
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Montefiore Medical Center Bronx, New York  10467-2490
University of South Alabama Mitchell Cancer Institute Mobile, Alabama  36604
Anne Arundel Medical Center Annapolis, Maryland  21401
Ellis Fischel Cancer Center Columbia, Missouri  65203
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Temple University Hospital Philadelphia, Pennsylvania  19140
University of California, San Francisco San Francisco, California  94143
Atlanta Cancer Care Atlanta, Georgia  30342
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Johns Hopkins University School of Medicine Baltimore, Maryland  21205
University of Pennsylvania Philadelphia, Pennsylvania  19104
SUNY Upstate Medical University Syracuse, New York  13210
University of Florida Gainesville, Florida  32610-0277
Yale University New Haven, Connecticut  06520
Ohio State University Columbus, Ohio  43210
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Chicago Chicago, Illinois  60637
USC Norris Comprehensive Cancer Center Los Angeles, California  90089
University of Kentucky Lexington, Kentucky  40536-0098
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Baylor Research Institute Dallas, Texas  75246
Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Sarah Cannon Research Institute Nashville, Tennessee  37203
Norton Cancer Institute Louisville, Kentucky  40207
University of California, Davis Sacramento, California  95818
University of Michigan Health System Ann Arbor, Michigan  
Center for Cancer and Blood Disorders, PC Bethesda, Maryland  20817
Swedish Neuroscience Institute Seattle, Washington  98122
Northwestern University Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois  60611-2941
LSU Health Sciences Center, Feist-Weiller Cancer Center Shreveport, Louisiana  71130
City of Hope Cancer Center Duarte, California  91010
Georgia Health Sciences University Augusta, Georgia  30912
Wake Forest Baptist Health Winston-Salem, North Carolina  27157
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center Durham, North Carolina  27710
University of Wisconsin Paul P Carbone Comprehensive Cancer Center Madison, Wisconsin  53792
UC San Diego Moores Cancer Center La Jolla, California  92093
North Shore University Health System Skokie, Illinois  60077
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center Phoenix, Arizona  85013
San Diego Pacific Oncology & Hematology Associates, Inc Encinitas, California  92024
Stanford Cancer Institute, Stanford University Stanford, California  94305
Mount Sinai Medical Center, Comprehensive Cancer Center Miami Beach, Florida  33140
Winship Cancer Institute, Emory University School of Medicine Atlanta, Georgia  30322
Covenant Clinic / Iowa Spine and Brain Institute Waterloo, Iowa  50702
Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center Lansing, Michigan  48912
St. Mary's of Michigan Medical Center/Field Neurosciences Institute Saginaw, Michigan  48604
New Jersey Neuroscience Institute, JFK Medical Center Edison, New Jersey  08818
Christiana Care Health Services Newark, New Jersey  19713
Dent Neurosciences Research Institute Amherst, New York  14226
The Long Island Brain Tumor Center at Neurology Surgery, P.C. Great Neck, New York  11021
Columbia University Medical Center - The Neurologic Institute of New York New York, New York  10032
Brain and Spine Surgeons of New York White Plains, New York  10604
University of Cincinnati Cancer Institute Cincinnati, Ohio  45267
University Hospitals, Case Medical Center (Cleveland) Cleveland, Ohio  44106
Providence Portland Medical Center, Oncology & Hematology Care Portland, Oregon  97213
Pacific Neurosurgical Portland, Oregon  97227
Lehigh Valley Physician Group-Hematology-Oncology Associates Allentown, Pennsylvania  18103
West Penn. Allegheny Health System Pittsburg, Pennsylvania  15212
Medical University of South Carolina - Department of Neuroscience Charleston, South Carolina  29425
University of Tennessee Medical Center - Knoxville Knoxville, Tennessee  37920
Texas Oncology Midtwon Austin, Texas  78705
The Methodist Neurological Institute Houston, Texas  77030
University of Utah Department of Neurosurgery Salt Lake City, Utah  84112
University of Virginia Healthcare System Charlottesville, Virginia  22908
University of Arizona Health Network Tucson, Arizona  85724
Kaiser Permanente Hawaii Moanalua Medical Center Honolulu, Hawaii  96819
Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute Minneapolis, Minnesota  55407