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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

Description

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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • Inclusion Criteria- Among other criteria, patients must meet the following conditions to be eligible for the study:
  • Adult patients, ≥ 18 years old
  • Newly diagnosed glioblastoma
  • Attempted surgical resection followed by conventional chemoradiation
  • Documented EGFRvIII positive tumor status by a Sponsor designated laboratory
  • No evidence of progressive disease from the post-operative period to the post-chemoradiation period
  • Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy
  • Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
  • WHO-ECOG Performance Status ≤ 2
  • 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:
  • Stereotactic biopsy only (without further surgical resection)
  • Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.
  • History, presence, or suspicion of metastatic disease
  • Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
  • Active systemic infection requiring treatment
  • 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, cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other carcinoma in situ that has been adequately treated and cured.
  • Planned major surgery
  • Evidence of current drug or alcohol abuse
  • 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
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial
  • Women who are pregnant or lactating

Sites

  • California

    • USC Norris Comprehensive Cancer Center, Los Angeles, California, 90033
    • City of Hope Cancer Center, Duarte, California, 91010
    • City of Hope Cancer Center, Duarte, California, 91010
    • Chao Family Comprehensive Cancer Center, Orange, California, 92868
    • Chao Family Comprehensive Cancer Center, Orange, California, 92868
    • San Diego Pacific Oncology & Hematology Associates, Inc, Encinitas, California, 92024
    • UC San Diego Moores Cancer Center, La Jolla, California, 92093
    • UC San Diego Moores Cancer Center, La Jolla, California, 92093
    • Stanford Cancer Institute, Stanford University, Stanford, California, 94305
    • Stanford Cancer Institute, Stanford University, Stanford, California, 94305
    • Kaiser Permanente, Redwood City Medical Center, Redwood City, California, 94063
    • Kaiser Permanente, Redwood City Medical Center, Redwood City, California, 94063
    • Alta Bates Summit Comprehensive Cancer Center, Berkeley, California, 94704
    • University of California, San Francisco, San Francisco, California, 94143
    • University of California, Davis, Sacramento, California, 95817
    • University of California, Davis, Sacramento, California, 95817
  • Arizona

    • Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix, Arizona, 85013
    • Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix, Arizona, 85013
    • University of Arizona Health Network, Tucson, Arizona, 85724
    • University of Arizona Health Network, Tucson, Arizona, 85724
  • Utah

    • University of Utah Department of Neurosurgery, Salt Lake City, Utah, 84112
    • University of Utah Department of Neurosurgery, Salt Lake City, Utah, 84112
  • Oregon

    • Providence Portland Medical Center, Oncology & Hematology Care, Portland, Oregon, 97213
    • Providence Portland Medical Center, Oncology & Hematology Care, Portland, Oregon, 97213
    • Pacific Neurosurgical, Portland, Oregon, 97227
    • Pacific Neurosurgical, Portland, Oregon, 97227
  • Washington

    • Swedish Neuroscience Institute, Seattle, Washington, 98122
    • Swedish Neuroscience Institute, Seattle, Washington, 98122
  • Texas

    • Texas Oncology Midtwon, Austin, Texas, 78705
    • Texas Oncology Midtwon, Austin, Texas, 78705
    • Baylor Research Institute, Dallas, Texas, 75246
    • Baylor Research Institute, Dallas, Texas, 75246
    • The Methodist Neurological Institute, Houston, Texas, 77030
    • The Methodist Neurological Institute, Houston, Texas, 77030
  • Nebraska

    • Southeast Nebraska Cancer Center, Lincoln, Nebraska, 68510
    • Southeast Nebraska Cancer Center, Lincoln, Nebraska, 68510
  • Louisiana

    • LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, 71103
    • LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, 71103
    • Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, 70809
  • Missouri

    • Ellis Fischel Cancer Center, Columbia, Missouri, 65203
    • Ellis Fischel Cancer Center, Columbia, Missouri, 65203
    • Washington University in St. Louis, St. Louis, Missouri, 63110
    • Washington University in St. Louis, St. Louis, Missouri, 63110
  • Arkansas

    • University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205
    • University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205
  • Iowa

    • Covenant Clinic / Iowa Spine and Brain Institute, Waterloo, Iowa, 50702
    • Covenant Clinic / Iowa Spine and Brain Institute, Waterloo, Iowa, 50702
  • Minnesota

    • Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute, Minneapolis, Minnesota, 55407
    • Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute, Minneapolis, Minnesota, 55407
  • Wisconsin

    • University of Wisconsin Paul P Carbone Comprehensive Cancer Center, Madison, Wisconsin, 53792
    • University of Wisconsin Paul P Carbone Comprehensive Cancer Center, Madison, Wisconsin, 53792
    • Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
    • Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
  • Illinois

    • Loyola University Medical Center, Maywood, Illinois, 60153
    • Rush University Medical Center, Chicago, Illinois, 60612
    • North Shore University Health System, Evanston, Illinois, 60201
    • North Shore University Health System, Evanston, Illinois, 60201
    • University of Chicago, Chicago, Illinois, 60637
    • Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, 60611
  • Alabama

    • University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, 36604
    • University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, 36604
    • University of Alabama at Birmingham, Birmingham, Alabama, 35294
  • Tennessee

    • Sarah Cannon Research Institute, Nashville, Tennessee, 37203
    • Sarah Cannon Research Institute, Nashville, Tennessee, 37203
    • Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232
    • Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232
  • Kentucky

    • Norton Cancer Institute, Louisville, Kentucky, 40202
    • Norton Cancer Institute, Louisville, Kentucky, 40202
  • Ohio

    • University of Cincinnati Cancer Institute, Cincinnati, Ohio, 45267
    • University of Cincinnati Cancer Institute, Cincinnati, Ohio, 45267
  • Michigan

    • Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center, Lansing, Michigan, 48912
    • Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center, Lansing, Michigan, 48912
  • Georgia

    • Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia, 30322
    • Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia, 30322
    • Atlanta Cancer Care, Atlanta, Georgia, 30005
    • Atlanta Cancer Care, Atlanta, Georgia, 30005
  • France

    • Institut Gustave Roussy, Villejuif, 94805
    • Institut Gustave Roussy, Villejuif, 94805
    • Service de Neurologie-GH, Paris, 75013
    • Service de Neurologie-GH, Paris, 75013
    • Centre Eugene Marquis, Rennes, 35042
    • Centre Eugene Marquis, Rennes, 35042
  • Israel

    • Soroka University M.C., Beer-Sheva, 84101
    • Soroka University M.C., Beer-Sheva, 84101
  • Taiwan

    • Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, 83301
    • Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, 83301
  • Sinaloa

    • Ensayos Clínicos y Medicina de Alta Especialidad, S.C., Culiacán, Sinaloa, 80020
    • Ensayos Clínicos y Medicina de Alta Especialidad, S.C., Culiacán, Sinaloa, 80020
  • Germany

    • Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672, Heidelberg, 69120
    • Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672, Heidelberg, 69120
  • Mexico

    • Hospital Central "Ignacio Morones Prieto", San Luis Potosí, 78240
    • Hospital Central "Ignacio Morones Prieto", San Luis Potosí, 78240
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