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A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

Description

This Phase II study will enroll patients into three groups. Group 1 are patients who have never been treated with bevacizumab. These patients will be randomly assigned to receive either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for Group 1 will be blinded. Group 2 and Group 2C patients are those who are refractory to bevacizumab (experienced recurrence or progression of glioblastoma while on bevacizumab or within 2 months of discontinuing bevacizumab). These patients will all receive rindopepimut/GM-CSF along with bevacizumab. Patients will be treated until disease progression or intolerance and all patients will be followed for survival. Patients may be treated with other therapies that are not part of the study after discontinuing treatment with the study vaccine.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Among other criteria, patients must meet the following conditions to be eligible for the study:
  • Age ≥18 years of age.
  • Histologic diagnosis of glioblastoma (WHO Grade IV).
  • Documented EGFRvlll positive tumor status (central lab confirmation).
  • First or second relapse of de novo glioblastoma or first diagnosis or first relapse of secondary glioblastoma.
  • Previous treatment must include surgery, conventional radiation therapy and temozolomide (TMZ).
  • Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy.
  • KPS of ≥ 70%.
  • If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of dexamethasone or equivalent per day during the week prior to Day 1.
  • Evaluable disease in Groups 1 and 2; measurable disease in Group 2C
  • Life expectancy > 12 weeks.
  • Patients in Group 2 and 2C must have had disease progression while receiving bevacizumab or within 2 months of treatment with bevacizumab.

  • Among other criteria, patients who meet the following conditions are NOT eligible for the study:
  • Subjects unable to undergo an MRI with contrast.
  • History, presence, or suspicion of metastatic disease
  • Prior receipt of vaccination against EGFRvIII.
  • Any known contraindications to receipt of study drugs, including known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE

Sites

  • California

    • Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027
    • University of Southern California (USC) Norris Comprehensive Cancer Center, Los Angeles, California, 90089
    • University of Southern California (USC) Norris Comprehensive Cancer Center, Los Angeles, California, 90089
    • UC Irvine Chao Family Comprehensive Cancer Center, Orange, California, 92868
    • UC Irvine Chao Family Comprehensive Cancer Center, Orange, California, 92868
    • Stanford Cancer Institute, Stanford University, Stanford, California, 94305
    • University of California San Francisco, San Francisco, California, 94143
    • University of California San Francisco, San Francisco, California, 94143
  • Nevada

    • S. Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106
  • Arizona

    • St. Joseph's Hospital and Medical Center / Barrow Neurological Institute, Phoenix, Arizona, 85013
    • St. Joseph's Hospital and Medical Center / Barrow Neurological Institute, Phoenix, Arizona, 85013
  • Utah

    • Utah Cancer Specialists, Salt Lake City, Utah, 84116
    • Utah Cancer Specialists, Salt Lake City, Utah, 84116
  • Oregon

    • Legacy Research Institute, Portland, Oregon, 97232
    • Legacy Research Institute, Portland, Oregon, 97232
  • Colorado

    • University of Colorado, Denver, Aurora, Colorado, 80045
    • University of Colorado, Denver, Aurora, Colorado, 80045
  • Washington

    • University of Washington Medical Center, Seattle, Washington, 98195
    • Swedish Neuroscience Research, Seattle, Washington, 98122
    • Swedish Neuroscience Research, Seattle, Washington, 98122
  • Texas

    • Texas Oncology Midtown, Austin, Texas, 78705
    • Texas Oncology Midtown, Austin, Texas, 78705
    • Baylor Research Institute, Dallas, Texas, 75246
    • UT Health Science Center, Houston Memorial Hermann Hospital, 6400 Fannin Street, #2800, Houston, Texas, 77030
    • UT Health Science Center, Houston Memorial Hermann Hospital, 6400 Fannin Street, #2800, Houston, Texas, 77030
  • Minnesota

    • John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR, Minneapolis, Minnesota, 55407
    • John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR, Minneapolis, Minnesota, 55407
  • Missouri

    • Washington University School of Medicine, St. Louis, Missouri, 63110
  • Illinois

    • Rush University Medical Center, Chicago, Illinois, 60612
    • NorthShore University Health System, Evanston, Illinois, 60201
    • NorthShore University Health System, Evanston, Illinois, 60201
  • Tennessee

    • Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232
  • Alabama

    • University of Alabama at Birmingham, Birmingham, Alabama, 35294
  • Ohio

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

    • Sparrow Cancer Center, Lansing, Michigan, 48912
    • Sparrow Cancer Center, Lansing, Michigan, 48912
  • Georgia

    • Atlanta Cancer Care, Atlanta, Georgia, 30342
    • Atlanta Cancer Care, Atlanta, Georgia, 30342
    • Piedmont Atlanta Hospital, Atlanta, Georgia, 30309
    • Piedmont Atlanta Hospital, Atlanta, Georgia, 30309
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