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University of Cincinnati Academic Health Center
Publish Date: 05/04/01
Media Contact: AHC Public Relations, (513) 558-4553
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Gene Therapy for Oral Cancers

Cincinnati--Lyon Gleich, MD, a head and neck cancer expert and associate professor in otolaryngology at the University of Cincinnati (UC) College of Medicine, is currently conducting a new study, using genetic therapy to target mouth and throat cancer. Cancers of the mouth and throat make up 5 percent of human cancers, but are difficult to treat and often recur after surgical removal.

Traditional treatment of mouth and throat cancers includes surgery and possibly radiation. In this new study, Gleich injects the tumors (which can usually be seen with the naked eye) with a gene therapy drug to get the immune system to recognize and attack the tumor as it would other invasive foreign bodies. Then Gleich's team removes the tumor, and checks the patient periodically to see if a recurrence of the cancer is prevented.

The initial phase I clinical trials of the study were conducted on patients with highly advanced cancer over a three-year period to demonstrate the safety of the new gene therapy. The early part of the study showed the new treatment was modestly effective even on the advanced cancers, and 20 patients survived for more than two years after the treatment. "Now that the treatment has been shown to be safe, we are beginning phase II trials to measure its effectiveness in combination with standard therapy for patients with head and neck cancer," Gleich said.

During phase II of the trial, the tumors in the mouth or throat are treated with Allovectin-7 injections prior to surgical removal of the cancer. Gleich and the UC head and neck cancer team observe and record whether there is any shrinkage of the tumor after the injections and if the drug prevents recurrence.

In this phase II study, patients with early mouth cancers are being treated. In the phase I studies, the gene therapy was a last hope for people with advanced cancer who had failed standard therapy. If this gene therapy shrinks the tumors or proves to prevent a recurrence of cancer, it will provide a model by which other gene-related cancers and diseases can be treated. More importantly, the therapy is injected directly into the tumor and targets the cancer, but does not injure non-cancerous cells which contribute to a patient's overall good health. "Genetic therapy of this type may prove to be one of the more gentle, yet effective, disease treatments to evolve from the new developments in human genomics," Gleich said.

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