Cancer

Title
The Study of an Investigational Medication in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma.
Trial Number
204148011812
Number of Participants
440
Principal Investigator

Kevin Barton

M.D.
Hematology/Oncology
Associate Professor
Eligibility

Participants may be included in the study only if they meet all of the following inclusion criteria at the time of randomization:
• Histologically confirmed, newly diagnosed, de novo glioblastoma including the following recognized variants of glioblastoma: small cell glioblastoma, giant cell glioblastoma, gliosarcoma and glioblastoma with oligodendroglial component (central pathologic review will be performed and histologic confirmation will be required prior to study entry).
• Attempted surgical resection followed by conventional chemoradiation,
• Tumor tissue specimens (paraffin-embedded) from surgical resection must be available for central pathology review, MGMT status determination and analysis of EGFRvIII status.
• Brain MRIs from the post-operative period (ideally obtained within 72 hours of surgery) and post-chemoradiation period (within one to14 days of completion of chemoradiation) available for submission to the independent review committee by the time of randomization.
• No evidence of progressive disease from the post-operative period to the post-chemoradiation period, based on changes in the neurologic exam, steroid use, or evident radiographic progression, according to RANO criteria.
• Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy.
• Systemic corticosteroid therapy at =2 mg of dexamethasone or equivalent per day for at least three days before randomization.
• WHO-ECOG Performance Status (Appendix 3) = 2 throughout the week prior to randomization.
• Men or women who are 18 years of age or older

Purpose

The purpose of this research study is to find out the good and bad effects of adding an investigational vaccine, rindopepimut (also known as CDX-110), to the chemotherapy drug called temozolomide in patients with brain tumors.

Enrollment

(708) 327-2831

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