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The primary objective is to evaluate overall survival in glioma patients receiving the vaccination. The trial is designed to enroll approximately 30 patients with recurrent high-grade glioma.
Patients will undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines. Eligible patients will be treated after surgery with oncophage once weekly for four weeks, followed by biweekly injections until vaccine depletion.
Andrew Parsa, assistant professor in the department of neurological surgery at the University of California, San Francisco, and principal investigator of the trial, said: "We are highly encouraged by the preliminary Phase I results in which we observed prolonged overall survival when compared with historical controls, as well as a tumor-specific immune response in all treated patients. Commencement of this Phase II trial with Oncophage (vitespen) is an important milestone in the advancement of this novel therapy and represents a potentially important next step in the treatment of this devastating disease."