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

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Study Number:
CDX110-06

Topic:
Glioblastoma

Principal Investigator:
Chaudhary

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 the investigational drug rindopepimut and GM-CSF to bevacizumab (also known as Avastin) helps to shrink brain tumors, prevent brain tumors from growing, or help subjects with brain tumors live longer than treatment with bevacizumab alone. You may be taking part in this study for up to 2 years.  During the treatment phase you will have visits on day 1, day 15, day 29 and every 28 days thereafter, until your disease progresses, you have serious side effects to the study treatment, or the sponsor decides to stop the study.  After the screening and treatment phase, you will have follow up visits every 2 months.  Even if you stop study 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 2 months until the study is over. This study will be conducted at approximately 20 centers across the world and will include approximately 95 patients.  About 21 people will enroll at the University of Cincinnati.

Qualifications:
To be eligible for the study you must be 18 years old with relapsed 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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