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

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT01498328 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-155

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
David Reardon, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
Jorg Dietrich, M.D., Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Lisa Doherty, ldoherty1@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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. Previous treatment for glioblastoma must include surgery,conventional radiation therapy and temozolomide (TMZ). 4. First or second relapse of primary glioblastoma. 5. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy. 6. KPS of ≥ 70%. 7. Life expectancy > 12 weeks. 8. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory. 9. 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. 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.
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