Henry Ford Hospital's Hermelin Brain Tumor Center is the first U.S. hospital to start a new clinical trial for Toca 511 & Toca FC, a combination therapy under investigation for high-grade glioma (HGG), a fast growing, brain cancer that often recurs even after surgery, radiation treatment and chemotherapy.

The investigational treatment combines Toca 511 (vocimagene amiretrorepvec), a biologic drug, with Toca FC, an extended-release tablet containing the antibiotic flucytosine.

"The combination of Toca 511 and  flucytosine has been shown in mouse studies to destroy brain cancer tumors, leave healthy tissue unharmed, and extend survival in most animals," said Steven Kalkanis, M.D., co-director of the Hermelin Brain Tumor Center.

Glioma is very difficult to treat successfully because, rather than being a clearly defined mass, the tumor blends with healthy brain tissue and sends out tentacles of microscopic cancer cells.

Standard treatment begins with surgery to remove as much of the tumor as possible, followed by irradiating the brain and chemotherapy in an attempt to kill any remaining cancer cells. Even after these extreme measures, the cancerous tumor often returns.

"The focus of the clinical trial now being conducted at Henry Ford and other leading U.S. neuro-oncology centers takes a radically different approach to killing the virulent brain cancer," said Tom Mikkelsen, M.D., co-director of the Hermelin Brain Tumor Center.

In this clinical trial, immediately after surgeons remove as much of the recurrent high-grade glioma as possible, the biologic drug Toca 511 will be injected into the "bed," or portion of the brain from which the tumor was removed. Henry Ford Hospital is also participating in a similar clinical trial whereby Toca 511 is administered at the time of tumor biopsy.

After allowing time for Toca 511 to spread through the tumor, each patient begins a course of oral Toca FC tablets. If tolerated well, these courses will be repeated. An MRI scan will be performed every two months during the trial period to measure the treatment's effectiveness.

According to Tocagen, the San Diego-based biotechnology company that developed the investigational treatment, Toca 511 is designed to selectively deliver to cancer cells the genetic instructions to produce the cytosine deaminase (CD) enzyme, which can then convert the antibiotic flucytosine into the potent anti-cancer drug 5-FU inside the cancer cells.

Henry Ford is now screening patients for using this investigational therapy. To be eligible for the clinical trial, patients must be at least 18 years old and be considering surgery to remove a tumor that has recurred or progressed following surgery, radiation and chemotherapy with temozolomoide.