A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma (ReACT)
Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring EGFRvIII, Glioblastoma, Rindopepimut, CDX-110, Small cell, Giant cell, Brain Cancer, Brain Tumor, Gliosarcoma, oligodendroglial, radiotherapy, chemoradiation, Tumor, Bevacizumab, Relapsed, Returned, Recurrent, EGFR variant III
Eligibility Criteria
Inclusion 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.
Exclusion Criteria:
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®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
- Use of non-protein based investigational therapy within 14 days prior to Day 1 or use of antibody-based investigational therapy within 28 days prior to Day 1.
- Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- Evidence of recent hemorrhage on screening MRI of the brain
- Evidence of current drug or alcohol abuse.
- Patients in Group 1 must not have received prior treatment with bevacizumab.
Sites / Locations
- University of Alabama at Birmingham
- St. Joseph's Hospital and Medical Center / Barrow Neurological Institute
- Kaiser Permanente Los Angeles Medical Center
- University of Southern California (USC) Norris Comprehensive Cancer Center
- UC Irvine Chao Family Comprehensive Cancer Center
- University of California San Francisco
- Stanford Cancer Institute, Stanford University
- University of Colorado, Denver
- Memorial Cancer Institute
- Orlando Health, Inc.
- Tampa General Hospital
- Piedmont Atlanta Hospital
- Atlanta Cancer Care
- Rush University Medical Center
- University of Chicago
- NorthShore University Health System
- The Johns Hopkins Hospital
- Dana-Farber Cancer Institute and Mass General Hospital
- University of Michigan Comprehensive Cancer Center
- Sparrow Cancer Center
- John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR
- Washington University School of Medicine
- New Jersey Neuroscience Institute JFK Medical Center
- Hackensack University Medical Center
- Dent Neurologic Institute, 3980 Sheridan Dr, 3rd Flr Clinical Rsch
- The Long Island Brain Tumor Center at Neurology Surgery, P.C.
- University of Rochester Medical Center
- Stony Brook University Hospital
- The Preston Robert Tisch Brain Tumor Center; Duke University Medical Center
- Wake Forest Baptist Health
- University of Cincinnati Cancer Institute
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
- Legacy Research Institute
- Lehigh Valley Hospital-John and Dorothy Morgan Cancer Center
- University of Pennsylvania
- University of Pittsburgh Cancer Institute
- Rhode Island Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Oncology Midtown
- Baylor Research Institute
- UT Health Science Center, Houston Memorial Hermann Hospital, 6400 Fannin Street, #2800
- Utah Cancer Specialists
- Swedish Neuroscience Research
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut.
Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control
Group 2 and 2C: Refractory to Bevacizumab
About half of the patients who have never received treatment with bevacizumab will receive rindopepimut/GM-CSF in a blinded fashion in combination with bevacizumab.
About half of the patients who have never received treatment with bevacizumab will receive KLH in a blinded fashion in combination with bevacizumab.
Patients with progressive disease while currently on or within two months after discontinuing bevacizumab will be administered rindopepimut/GM-CSF while continuing (or restarting if they had stopped bevacizumab).