Media Contact: Sandra VanE-mail: [email protected]Telephone: 1-800-396-1002
LOS ANGELES (April 3, 2001) - A clinical trial to study the effectiveness of Temodar (temozolomide), the first new brain cancer fighting drug to receive FDA approval in more than 20 years, is underway at Cedars-Sinai Medical Center's Maxine Dunitz Neurosurgical Institute. "We at the Maxine Dunitz Neurosurgical Institute are particularly pleased to be involved in this study," said Keith Black, M.D., director of the Institute. "It enables us to continue fulfilling our mission of providing patients with a devastating group of diseases - brain tumors -- with access to the most advanced, novel and innovative treatments."
The study will focus on patients with mixed gliomas or oligodendroglial tumors, and will involve physicians and researchers not only at Cedars-Sinai, but from throughout the greater Los Angeles area. It is expected to include approximately 60 patients over a 30-month period.
According to Paul Zeltzer, M.D., a neuro-oncologist at the Neurosurgical Institute and lead investigator in this study, mixed glioma brain tumors, which typically occur to people in their 20s, 30s and 40s, were historically treated only by surgery and radiation. Then about 10 years ago, scientists learned that although most types of brain tumors are resistant to chemotherapy, mixed gliomas are actually one of the most responsive to this type of treatment.
With this discovery, physicians began following surgery and radiation therapy with a regimen of chemotherapy that included the cancer-fighting drugs Procarbazine, CCNU and Vincristine (PCV). With this PCV "cocktail," seven-year survival rates for patients with mixed gliomas increased from approximately 20 percent using surgery and radiation alone, to 50 - 70 percent. However, longer-term survival rates have continued to remain low, due to the fact that the tumor grows back, even 10 years later.
Researchers in the Temodar clinical trial hope that by treating newly diagnosed patients first with Temodar for a longer period of time, then following it with a regimen of PCV, that tumors will be arrested earlier and that recurrence rates will be reduced. Participants in the Temodar study will be given capsules of the drug daily for six weeks, followed by a rest period of four weeks. Depending on how the tumor responds, this cycle may be repeated once more. Dr. Zeltzer thinks that by using new genetic information showing whether an individual patient's tumor is more or less likely to respond to chemotherapy, the team will be better able to pinpoint the most effective treatment options on a case-by-case basis.
An estimated 17,000 - 25,000 patients are diagnosed each year with malignant gliomas, 10 percent to 25 percent of whom have mixed gliomas. In addition to studying the drug's effect on newly diagnosed brain tumor patients, physicians participating in the clinical trial will also study the effectiveness of Temodar on patients who have not responded well to conventional PCV or other therapies.
"We hope to put more patients into remission early and to have fewer relapses later on," said Dr. Zeltzer.
Temodar is manufactured by Schering-Plough, which, through one of its subsidiaries, Integrated Therapeutics Group, is providing an unrestricted research grant for data management in this study.
Schering-Plough Corporation of Kenilworth, NJ is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.
Cedars-Sinai Medical Center is one of the largest and finest non-profit hospitals in the Western United States. For the fifth straight two-year period, the hospital has been named Southern California's gold standard in healthcare in an independent survey. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthrough biomedical research and superlative medical education. The medical center ranks among the top 12 non-university hospitals in the nation for its research activities.
For information on participating in this study, please call the Cedars-Sinai Maxine Dunitz Neurosurgical Institute at 310-423-7900.
# # #
For media information and to arrange an interview, please call 1-800-396-1002. Thanks for not publishing this number in stories. This news release, plus other news information from Cedars-Sinai Medical Center, is available on Newswise at http://www.newswise.com.
RSS