SUMMIT, NJ -  Following successful Phase 1 clinical trials, the Toca regimen – a new immunotherapy for patients with recurrent brain cancer – has advanced to a Phase 3 study, which is currently underway. The trial is being conducted at 68 sites across the United States, Canada, Israel and South Korea, including at Overlook Medical Center’s Gerald J. Glasser Brain Tumor Center, one of three clinical trial sites in New Jersey.

In this surgical study, patients are randomized to either standard of care treatment or the Toca regimen. Enrollment is expected to complete in this trial by the end of 2018.

“Toca 5 uses a virus to stimulate a patient’s own immune system and attack recurring high-grade gliomas – glioblastoma and anaplastic astrocytoma,” explains Yaron Moshel, MD, PhD, a neurosurgeon with Atlantic Neurosurgical Specialists and co-director of the Gerald J. Glasser Brain Tumor Center who is Principal Investigator (PI) for the local arm of the study at Overlook Medical Center. 

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Patients randomized to the Toca regimen receive an investigational treatment that involves two discrete steps. During the first step, patients receive Toca 511 (vocimagene amiretrorepvec), a replicating virus that selectively infects cancer cells, at the time of surgery. After a few weeks, they then take cycles of Toca FC (extended-release 5-fluorocytosine), a potent anti-cancer pill that kills cancerous cells and activates immune cells selectively against cancerous ones, leaving healthy cells unharmed. 

“Data from Phase 1 testing of the Toca regimen showed a favorable safety profile, complete tumor shrinkage, and extended patient longevity compared to other therapies,” Dr. Moshel continues.

With the current standard of care, newly diagnosed patients with glioblastomas have a median survival of approximately 14 to 16 months. After recurrence, median survival is typically seven to nine months.

“In contrast, Phase 1 results of the immunotherapy trial showed median longevity of 14.4 months for patients with recurrent disease and patients with complete tumor shrinkage are still alive almost three years after starting the Toca regimen,” adds Dr. Moshel. “These results are encouraging – for patients, their loved ones and the medical community – and we look forward to sharing further findings from Phase 3 within the next 18 months.

Specialists at the Gerald J. Glasser Brain Tumor Center treat a variety of brain tumors and related conditions, including acoustic neuromas and schwannomas; anaplastic astrocytomas, oligodendrogliomas and low-grade gliomas; brain, epidural and leptomeningeal metastases; ependymomas; glioblastomas; low-grade astrocytomas; lymphomas; meningiomas; medulloblastomas; peripheral nerve, pineal and pituitary tumors; rare glial and neuronal tumors; sarcomas; and spinal cord tumors.

The center features a multidisciplinary panel of experts who specialize in neurosurgery, skull base surgery, neuroradiology, radiation oncology, neuro-oncology, medical oncology, neurology, neuropathology and social work. Overlook Medical Center also has the largest CyberKnife program in the tri-state area for the treatment of brain tumors. The brain tumor center recently moved into its own space on the main level of Overlook Medical Center, in order to foster an optimal, convenient patient-centered experience.

For more information, visit research.atlantichealth.org/Toca511, or contact Patrice Light, research nurse coordinator, Gerald J. Glasser Brain Tumor Center, at 908-522-5768.