Seeking Adults with Newly Diagnosed Glioblastoma


16533

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

Neurology

Purow Benjamin, W

UVA Health System seeks men and women 18 years and older, with newly diagnosed glioblastoma (GBM) brain cancer following surgery, to participate in a clinical research study. The purpose of this study is to compare how well the investigational cancer vaccine, Rindopepimut (CDX-110), improves overall survival versus standard-of-care treatment only in patients with newly diagnosed GBM that have a mutation called EGFRvIII (present in about 35% of GBM). Standard-of-care treatment for GBM typically combines surgery, radiation therapy, and chemotherapy. Radiation therapy is in the form of external beam radiation administered for approximately 6 weeks. Temozolomide (Temodar), an oral medication, is the standard chemotherapy drug used, and is taken at the same time as radiation therapy. Rindopepimut (CDX-110) is an investigational agent in this study – it is not yet FDA-approved for glioblastoma or any other indication. Patients with newly diagnosed GBM (including small cell GBM, giant cell GBM, gliosarcoma, and GBM with oligodendroglial component), and who have undergone surgical resection of the tumor are eligible to undergo additional screening procedures. Tumor tissue specimens from surgical resection must be available for central pathology review to determine EGFRvIII status. Patients who meet eligibility criteria, complete the screening process, and are enrolled into the study will be randomized to receive either Rindopepimut (CDX-110) or control vaccine (placebo). You will have a 50% chance of receiving the study drug and a 50% chance of receiving the placebo. Neither you nor the study doctor will know which medication you will receive, but in the event of an emergency, this information can be obtained. Rindopepimut (CDX-110) or control vaccine (placebo) is administered via injection approximately once per month once radiation is finished. You will receive the study drug for 6-12 months as long as you do not experience tumor growth (as documented by MRI) and/or experience unacceptable drug effects. Participants in this study will have routine neurological and physical exams performed as well as tumor evaluations done by MRI. Blood and urine samples will be collected for routine, or standard of care, testing. Additional blood will be collected at certain times for specific research tests required by the study. You will not receive any payment for participating in this study. For more information, or to see if you qualify to take part in this study, please contact: Contact: Monika Thielen Phone: (434)-243-9900 Email: mjt3c@virginia.edu Primary Investigator: Benjamin Purow, MD IRB-HSR# 16533


Adult

Brain Cancer
Brain Tumor
Glioblastoma

Neurosurgery
Neurology
Neuro-Oncology
Cancer (Oncology)

Ill

No Compensation

Monica Thielen

mjt3c@virginia.edu

4342439900