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

Completed · Phase 2

Conditions studied: Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component, Recurrent Glioblastoma, Relapsed Glioblastoma

In brief

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 drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.

Key facts

Study ID

NCT01498328

Run by

Celldex Therapeutics

People needed

127

Starts

2011-12-01

Expected to finish

2016-05-17

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• St. Joseph's Hospital and Medical Center / Barrow Neurological Institute — Phoenix, Arizona, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• University of Southern California (USC) Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UC Irvine Chao Family Comprehensive Cancer Center — Orange, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford Cancer Institute, Stanford University — Stanford, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• Memorial Cancer Institute — Hollywood, Florida, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• Atlanta Cancer Care — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute and Mass General Hospital — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Sparrow Cancer Center — Lansing, Michigan, United States
• John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New Jersey Neuroscience Institute JFK Medical Center — Edison, New Jersey, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Dent Neurologic Institute, 3980 Sheridan Dr, 3rd Flr Clinical Rsch — Amherst, New York, United States

Full record on ClinicalTrials.gov

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