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

Not Recruiting

Trial ID: NCT01498328

Purpose

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.

Official Title

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

Stanford Investigator(s)

Gordon Li, MD
Gordon Li, MD

Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)

Eligibility


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.

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the
study:

   1. Subjects unable to undergo an MRI with contrast.

   2. History, presence, or suspicion of metastatic disease

   3. Prior receipt of vaccination against EGFRvIII.

   4. 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.

   5. 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.

   6. Clinically significant increased intracranial pressure (e.g., impending herniation),
   uncontrolled seizures, or requirement for immediate palliative treatment

   7. Evidence of recent hemorrhage on screening MRI of the brain

   8. Evidence of current drug or alcohol abuse.

   9. Patients in Group 1 must not have received prior treatment with bevacizumab.

Intervention(s):

drug: Bevacizumab

drug: Rindopepimut (CDX-110) with GM-CSF

drug: KLH

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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