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NOVEMBER 3, 2005
  Penn Researchers Study New Approach to Extend Lives of People with Deadliest Brain Tumors
  Clinical trial participants may receive novel drug-delivery method that attacks remaining cancerous cells following surgical removal of tumors
   

(Philadelphia, PA) - Researchers at the University of Pennsylvania Health System are studying the effectiveness of a novel drug-delivery approach that attacks only cancerous cells in the brain to extend the lives of people with Glioblastoma Multiforme (GBM), the most common and aggressive form of primary brain tumors. A highly malignant tumor that can double in size in 30 days, GBM infiltrates the normal brain tissue surrounding the tumor. Each year 10,000 Americans are diagnosed with GBMs, and the median survival time after detection is 12 months.

Currently there are very limited treatment options to prevent the rapid recurrence or progression of the tumor. However, preliminary results of the clinical trials at Penn, called the “PRECISE Study” using the new experimental drug IL13-PE38QQR (IL13), show great promise, says Kevin D. Judy, MD, Associate Professor, Department of Neurosurgery at Penn, and the study’s principal investigator. “The drug works like Pac Man,” notes Judy. “It goes in and eats only the leftover tumors and is harmless to healthy brain cells. Given this monstrous disease, one of the challenges is to search for therapies selected to attack only tumors and not the good tissue, which is what IL13 does.”

Through convection-enhanced delivery (CED), an experimental method using positive pressure infusion, the IL13 is delivered directly in the area at risk for remaining tumor cells after the tumor is removed. “The way the drug is distributed is a very important component of this study,” Judy says. “The placement of the catheters is the key to get the drug distributed in the right areas to kill those stray cells.”

There are about 50 participating hospitals, and the University of Pennsylvania Health System is the only from the region in the study. “It is one of the largest and most comprehensive clinical trials ever conducted to identify new and more effective treatments for recurrent GBM,” says Judy.

The median survival rate for 97 patients on IL13 almost doubled from 26 weeks to 44 weeks. Several patients have survived for more than three years, and the U.S. Food and Drug Administration (FDA) has granted IL13 rare fast-track designation to accelerate its approval.

The Phase III PRECISE trial looks at the patient’s overall survival, quality of life during treatment, and safety of IL13, compared to patients treated with GLIADEL® Wafer in the treatment of first recurrent GBM following removal of the tumor. Patients have a 2 out of 3 chance to receive the IL13 and a 1 out of 3 chance to receive GLIADEL. GLIADEL is a form of BCNU, a known cancer drug that is currently approved by the FDA and sold for the treatment of recurrent or newly diagnosed GBM. GLIADEL extends median survival by eight weeks.

Patient Sonia Goldstein Participates in Penn Study
Knowing her family’s predisposition for dementia, Sonia Goldstein decided to get an MRI, but did not expect to hear that a brain tumor was detected during her exam. When they learned the alarming news, friends directed her to Dr. Kevin Judy.

In August 2004, Judy surgically removed Goldstein’s primary tumor, but despite radiation and chemotherapy, the tumor grew back in Spring 2005. In May 2005, Judy performed surgery to remove the recurrent tumor and four days later inserted four catheters into the surrounding area of her brain. The IL13 was then delivered directly in the area at risk for remaining tumor cells for the next 96 hours.

“I was so happy to have the option to participate in the study and to be chosen to receive this new treatment,” Goldstein says.

For Goldstein and her husband of 53 years, Bennett, the outcome has given them more treasured time together with their two children and four grandchildren. MRIs given every three months confirm the continued effectiveness of the treatment. Her husband says she is a “pillar of the community,” and continues to enjoy traveling and social events at her synagogue.

For additional information on the PRECISE trial at Penn, call (215) 662-6462. For general information, visit www.PreciseTrial.com.

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