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Experimental Agent May Enhance Effects of Radiation on Patients with Brain Metastases

Pittsburgh, February 16, 2000 -- Early results from an ongoing research study suggest that an experimental agent, Xcytrin™ (motexafin gadolinium), enhances the cancer-killing effects of radiation and may lead to significant tumor shrinkage and improvements in survival and brain function in patients with the most common type of brain tumor.

The phase III clinical trial is being conducted at more than 40 centers in the United States, Canada and Europe, including the University of Pittsburgh Cancer Institute (UPCI). The trial focuses on patients with brain metastases, which are tumors that occur when cancer spreads from another part of the body. Nearly 150,000 cases of brain metastases are diagnosed annually in the United States, compared to 17,000 cases of primary brain tumors. Patients with brain metastases may experience a variety of symptoms, including seizures, decreased neurological function and problems with balance and memory.

"This is one of the first studies to look critically at four important factors related to brain metastases: survival, quality of life, tumor progression and patients' neurological function," said David Schiff, MD, principal investigator of the study and assistant professor of neurosurgery and medical oncology. "So far, initial results for this drug are encouraging in these four areas."

Patients in the study are randomly assigned to receive either experimental treatment with Xcytrin plus standard whole-brain radiation therapy, or treatment with radiation alone. Patients receiving Xcytrin are given intravenous injections of the drug about two hours before undergoing radiation treatment. Patients generally receive 10 such treatments over a two-week period.

Results of the lead-in portion of the study were presented at the recent annual meeting of the American Society for Therapeutic Radiology and Oncology. Twenty-five patients with brain metastases received Xcytrin prior to whole-brain radiation therapy. Magnetic resonance imaging results were available for only 19 patients. Of those, significant tumor shrinkage --defined as tumor volume reduction of at least 50 percent -- was found in 13 patients. Among the full group of 25 patients, 19 maintained or improved brain function, while only one died because of brain tumor progression.

Side effects of Xcytrin observed to date were minor, and included temporary facial discoloration, change in urine color and nausea in some patients.

Plans are to enroll 425 patients in this ongoing study among all participating centers. For more information about this study, please call Mary McLaughlin, R.N., at UPCI's Brain Tumor Center, at (412) 647-5369.

As the only National Cancer Institute-designated comprehensive cancer center in western Pennsylvania, UPCI is a recognized leader in providing innovative cancer prevention, detection, diagnosis and treatment; biomedical research; compassionate patient care and support; and community outreach services. UPCI investigators are world-renowned for their work in clinical and basic research on cancer.

For additional information on UPCI, please access http://www.upci.upmc.edu or call the Cancer Information and Referral Service at 1-800-237-4PCI (4724).