Huntsman Center part of clinical trial on cancer Rx

The Huntsman Cancer Institute has enrolled the first patient in a nationwide clinical trial to treat inoperable brain tumors using a medication that sticks to cancer cells and avoids healthy brain tissue.

Traditionally, patients with the malignant tumors, called Glioblastoma Multiforme, have an average life expectancy of less than a year after they're diagnosed, "despite aggressive therapy," said Dr. Randy Jensen, associate professor of neurosurgery at the U. and one of the clinical investigators. The tumor is "so intrusive it is hard to distinguish from the normal brain tissue. We never get all of them out" in surgery.

If results are positive, Jensen said neurologists hope patients with other conditions, such as Parkinson's and Alzheimer's, could benefit as well.

The medication is called TransMID, a modified diphtheria toxin that latches onto transferrin receptors on the cell's surface. When that happens, the toxin gets into the cells and kills them. But it doesn't bind to healthy brain cells.

"The hope is that it will selectively kill the tumor cells and leave the normal brain untouched and can potentially cure the brain tumor," he said.

A small catheter is placed into the brain tumor itself and the drug is slowly infused over four or five days, where it spreads throughout the tumor and surrounding brain tissue. The patient is hospitalized for those five days.

The entire process is repeated again a month later.

Current best treatment for the brain tumors includes surgery, then radiation, followed by "some systemic chemotherapies that haven't worked really well," Jensen said.

For the trial, patients are randomly assigned to the treatment or control group. All receive that standard treatment, but the TransMID is added for patients in the treatment group, who learn the day before surgery. The trial also includes a series of magnetic resonance imaging scans to note the results and whether the tumor shrinks or disappears.

Internationally, about 200 people will be enrolled in the study over the next year. The following year data will be collected and analyzed.

The drug is produced by Xenova Group, a biopharmaceutical company in the United Kingdom that focuses on cancer, addiction treatment and immunotherapy drugs.

The U.S. Food and Drug Administration gave the drug fast track status in August 2001 and orphan drug status in December that year, both recognizing the grave medical prognosis for patients with the high-grade malignant gliomas, the lack of good treatment options and that it is not a common condition.

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