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

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Study Number:
CDX110-04

Topic:
Glioblastoma

Principal Investigator:
Chaudhary

Addtional Investigators:
Christopher M McPherson
Ronald E Warnick

Ongoing:
Ongoing

Place:
Barrett Cancer Center; University Hospital; West Chester Hospital Medical Building

Overview:

The purpose of this research study is to find out whether adding an experimental vaccine product called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or possibly prevents brain tumors from growing which may help patients with brain tumors live longer than treatment with temozolomide alone. Temozolomide is a standard treatment for glioblastoma and all patients in this study will be administered temozolomide according to routine practice. The duration of participation in this study may be for 5 years or longer.  After the screening and experimental treatment phase, you will have follow-up visits every 3 months.  Even if you stop experimental treatment or go on to have other therapies to treat your glioblastoma, you will be asked to follow-up with the study doctor by telephone every 3 months until the study is over. This study will be conducted at 150 – 200 centers across the world and will include approximately 440 patients.  About ten (10) people will enroll at the University of Cincinnati.

Qualifications:
To be eligible for the study you must be at least 18 years old with newly diagnosed glioblastoma, whose tumors contain EGFRvIII (a protein which is found only in the cancer cells).

Contact:
For more information, please contact Alison Kastl, BS, CCRC, Director of Clinical Trials, at kastla@ucmail.uc.edu or (513) 584-0436.

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