Trial Information

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

The purpose of this research study is to find out whether adding the investigational drug rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or prevents brain tumors from growing and helps patients with brain tumors live longer than treatment with temozolomide alone. Temozolomide is a standard treatment for glioblastoma and all subjects in this study will be given temozolomide as standard care.

The study will also see how treatment affects your quality of life. Additional studies may be performed to see how your body’s immune system (the system your body uses to fight cancer, infections and “foreign bodies”) is reacting to the study treatment. The study will also see what side effects there are when injections of rindopepimut are given along with the commonly used temozolomide chemotherapy.

In this study you may receive the study drug CDX-110 with temozolomide or you may receive another drug (KLH) that is being used as a placebo with temozolomide. The placebo is KLH given as a “placebo” injection. A placebo injection is a shot that is given without any expected therapeutic benefit. The purpose of the placebo is to disguise which treatment you are receiving from you and your study doctor. KLH is one of the components (or parts) of the rindopepimut vaccine

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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Research Center Information: City of Hope

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