The Brain Tumor Research Center at the University of California, San Francisco, has begun enrolling patients into a phase 2 clinical trial of Oncophage (vitespen), in combination with the standard of care – radiation therapy plus Temodar (temozolomide) – for newly diagnosed glioma patients.
The goals of the investigator-sponsored study are to evaluate median overall survival, progression-free survival and immunologic response to vaccine treatment.
Reportedly, the phase 2 single-arm trial is designed to enroll about 60 patients with newly diagnosed glioma. Patients will undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines.
According to the protocol, patients will receive Oncophage once weekly for four consecutive weeks and monthly until vaccine depletion with concurrent Temodar.
Andrew Parsa, associate professor in the department of neurological surgery at the University of California, and principal investigator of the trial, said: “To date, improvements in overall survival for newly diagnosed glioma patients have been negligible. The rationale for moving Oncophage into this patient population and combining it with radiation and Temodar was underscored by the encouraging results from the ongoing Phase 2 study in recurrent glioma, a more challenging patient population where the results showed overall survival increasing to approximately 10.5 months.”