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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 FoundationCleveland, Ohio  44195
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington Medical CenterSeattle, Washington  98195-6043
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Loyola University Medical CenterMaywood, Illinois  60153
Fletcher Allen Health CareBurlington, Vermont  05401
Medical College of WisconsinMilwaukee, Wisconsin  53226
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
New York Methodist HospitalBrooklyn, New York  11215-3609
North Shore University HospitalManhasset, New York  11030
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Rochester Medical CenterRochester, New York  14642
Hartford HospitalHartford, Connecticut  06102-5037
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Montefiore Medical CenterBronx, New York  10467-2490
University of South Alabama Mitchell Cancer InstituteMobile, Alabama  36604
Anne Arundel Medical CenterAnnapolis, Maryland  21401
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Temple University HospitalPhiladelphia, Pennsylvania  19140
University of California, San FranciscoSan Francisco, California  94143
Atlanta Cancer CareAtlanta, Georgia  30342
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Johns Hopkins University School of MedicineBaltimore, Maryland  21205
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
SUNY Upstate Medical UniversitySyracuse, New York  13210
University of FloridaGainesville, Florida  32610-0277
Yale UniversityNew Haven, Connecticut  06520
Ohio State UniversityColumbus, Ohio  43210
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
University of ChicagoChicago, Illinois  60637
USC Norris Comprehensive Cancer CenterLos Angeles, California  90089
University of KentuckyLexington, Kentucky  40536-0098
John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Baylor Research InstituteDallas, Texas  75246
Southeast Nebraska Cancer CenterLincoln, Nebraska  68510
Sarah Cannon Research InstituteNashville, Tennessee  37203
Norton Cancer InstituteLouisville, Kentucky  40207
University of California, DavisSacramento, California  95818
University of Michigan Health SystemAnn Arbor, Michigan  
Center for Cancer and Blood Disorders, PCBethesda, Maryland  20817
Swedish Neuroscience InstituteSeattle, Washington  98122
Northwestern University Robert H. Lurie Comprehensive Cancer CenterChicago, Illinois  60611-2941
LSU Health Sciences Center, Feist-Weiller Cancer CenterShreveport, Louisiana  71130
City of Hope Cancer CenterDuarte, California  91010
Georgia Health Sciences UniversityAugusta, Georgia  30912
Wake Forest Baptist HealthWinston-Salem, North Carolina  27157
The Preston Robert Tisch Brain Tumor Center at Duke University Medical CenterDurham, North Carolina  27710
University of Wisconsin Paul P Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792
UC San Diego Moores Cancer CenterLa Jolla, California  92093
North Shore University Health SystemSkokie, Illinois  60077
Barrow Neurological Institute at St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85013
San Diego Pacific Oncology & Hematology Associates, IncEncinitas, California  92024
Stanford Cancer Institute, Stanford UniversityStanford, California  94305
Mount Sinai Medical Center, Comprehensive Cancer CenterMiami Beach, Florida  33140
Winship Cancer Institute, Emory University School of MedicineAtlanta, Georgia  30322
Covenant Clinic / Iowa Spine and Brain InstituteWaterloo, Iowa  50702
Edward W. Sparrow Hospital Association - Sparrow Regional Cancer CenterLansing, Michigan  48912
St. Mary's of Michigan Medical Center/Field Neurosciences InstituteSaginaw, Michigan  48604
New Jersey Neuroscience Institute, JFK Medical CenterEdison, New Jersey  08818
Christiana Care Health ServicesNewark, New Jersey  19713
Dent Neurosciences Research InstituteAmherst, 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 YorkNew York, New York  10032
Brain and Spine Surgeons of New YorkWhite Plains, New York  10604
University of Cincinnati Cancer InstituteCincinnati, Ohio  45267
University Hospitals, Case Medical Center (Cleveland)Cleveland, Ohio  44106
Providence Portland Medical Center, Oncology & Hematology CarePortland, Oregon  97213
Pacific NeurosurgicalPortland, Oregon  97227
Lehigh Valley Physician Group-Hematology-Oncology AssociatesAllentown, Pennsylvania  18103
West Penn. Allegheny Health SystemPittsburg, Pennsylvania  15212
Medical University of South Carolina - Department of NeuroscienceCharleston, South Carolina  29425
University of Tennessee Medical Center - KnoxvilleKnoxville, Tennessee  37920
Texas Oncology MidtwonAustin, Texas  78705
The Methodist Neurological InstituteHouston, Texas  77030
University of Utah Department of NeurosurgerySalt Lake City, Utah  84112
University of Virginia Healthcare SystemCharlottesville, Virginia  22908
University of Arizona Health NetworkTucson, Arizona  85724
Kaiser Permanente Hawaii Moanalua Medical CenterHonolulu, Hawaii  96819
Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience InstituteMinneapolis, Minnesota  55407