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Brain Tumor Center begins vaccine study

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Posted: Thursday, August 1, 2013 1:38 pm | Updated: 1:41 pm, Thu Aug 1, 2013.

Doctors at North Shore-LIJ’s Brain Tumor Center have begun enrolling patients in a new brain cancer vaccine study. Newly diagnosed glioblastoma patients have the option of joining an international, Phase III, Celldex ACT IV research study to test the efficacy of an investigational vaccine. 

“The purpose of this research study is to determine whether adding the investigational brain cancer vaccine rindopepimut to the standard chemotherapy drug temozolomide helps patients with newly diagnosed glioblastoma live longer,” said Michael Schulder, MD, principal investigator of the study at North Shore-LIJ and vice chair of neurosurgery at North Shore University Hospital and Long Island Jewish Medical Center. “Previous studies of patients who received rindopepimut and the standard chemotherapy drug had encouraging results compared to control patients who were treated with the chemotherapy drug alone,” Schulder added.

Glioblastoma is the most prevalent form of malignant primary brain tumor. The first stage of treatment is surgery to remove as much of the tumor as possible, followed by radiotherapy and chemotherapy.

Participants must be at least 18 years of age, been newly diagnosed with glioblastoma and had or are scheduled to have surgery to remove the tumor, and had or are scheduled to have post-surgery radiation and chemotherapy with temozolomide, without growth of tumor during this time. Participants must be a candidate for and agree to receive adjuvant temozolomide therapy and not have received other investigational treatments for glioblastoma. In addition, participants must have a tumor that test positive for the Epidermal Growth Factor Receptor, a growth factor receptor found in normal and malignant tumor cells.

All participants will be administered temozolomide.  Half the participants will be randomly assigned to receive the blinded vaccine rindopepimut and half the participants will be randomly assigned to receive a placebo. 

Participants will be treated in a blinded fashion– neither the patient nor the doctor will know which arm of the study the participant is on. All participants enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur. Study participants will be followed for survival until study completion, estimated to be up to five years or longer. 

For more information about the study or to see if you are eligible, call North Shore-LIJ’s Brain Tumor Center at (516) 562-3058 or go to neurocni.com.

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