A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed 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 drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Bevacizumab
  • drug : KLH
  • drug : Rindopepimut (CDX-110) with GM-CSF

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

Among other criteria, patients must meet the following conditions to be eligible for the study: 1. Age ?18 years of age. 2. Histologic diagnosis of glioblastoma (WHO Grade IV). 3. Documented EGFRvlll positive tumor status (central lab confirmation). 4. First or second relapse of de novo glioblastoma or first diagnosis or first relapse of secondary glioblastoma. 5. Previous treatment must include surgery, conventional radiation therapy and temozolomide (TMZ). 6. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy. 7. KPS of ? 70%. 8. 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. 9. Evaluable disease in Groups 1 and 2; measurable disease in Group 2C 10. Life expectancy > 12 weeks. 11. Patients in Group 2 and 2C must have had disease progression while receiving bevacizumab or within 2 months of treatment with bevacizumab.

External Links

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Contact information

Primary Contact:

Vani Jain 650-723-1005

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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