November 27, 2000
FOR IMMEDIATE RELEASE

CONTACT: Tom Rosenberger, APR, Communications Department (513) 569-5260
CONTACT: Cindy Starr, MSJ, Communications Department (513) 584-2214

CINCINNATI, OHIO Two clinical research studies are underway in Cincinnati for the treatment of glioblastoma multiforme, a very aggressive type of brain tumor. According to Ronald Warnick, MD, principal investigator and neurosurgeon with the Mayfield Clinic, The Neuroscience Institute, and the University of Cincinnati Brain Tumor Research Center, these trials represent novel treatment options for patients as the brain tumor progresses from initial diagnosis to later stages. The studies will determine the safety and effectiveness of these treatments in extending life and maintaining quality of life in patients with glioblastoma multiforme.

Glioblastoma is the most malignant brain tumor and accounts for approximately 6,500 patients each year in the U.S. The prognosis for the great majority of patients with glioblastoma is guarded. The average survival time with standard treatment is only 12 months. Current treatment options include surgery followed by radiation therapy, which usually reduces the size of the tumor. Chemotherapy is sometimes also administered, particularly in younger patients. Despite these options, the quality and length of life are limited for most patients.

For the people in Greater Cincinnati who are diagnosed with glioblastoma, the search for an effective therapy that can improve quality of life, as well as increase survival, is paramount, said Dr. Warnick. Both of these studies represent promising new frontiers in this search. A Phase I/II Trial of Conformal Radiotherapy and Hyperbaric Oxygen for Patients with Newly Diagnosed Glioblastoma The purpose of this trial is to determine the feasibility of administering hyperbaric oxygen (breathing oxygen at atmospheric pressures greater than sea level), in conjunction with three-dimensional conformal radiation (radiation beams shaped specifically to the size and shape of the brain tumor). The goal is to use hyperbaric oxygen to sensitize tumors to the effects of radiation. This study is specifically for patients with recently diagnosed glioblastoma multiforme, and they will participate in the study for one year.

The study is the only one of its kind in the United States, and is sponsored by The Neuroscience Institute, a neuroscience center of excellence located at The University Hospital and supported by The Health Alliance of Greater Cincinnati.

A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients with Recurrent Glioblastoma Multiforme The purpose of this clinical research trial is to evaluate a new investigational agent for glioblastoma multiforme called ADTI-015". DTI-015 (BCNU dissolved in ethanol) is injected directly into the tumor and rapidly diffuses throughout the tumor mass. This allows a high dose of BCNU to reach the tumor with minimal systemic effects. The study will help investigators determine the maximum tolerated dose of DTI-015 and whether the treatment can control glioblastoma without causing limiting adverse effects.

This study is specifically for patients with glioblastoma multiforme that has grown back after initial treatment. Patients will receive one of four dose levels of BCNU (45, 60, 75, 90 mg/ml), by direct injection into the tumor. Patients who enter this study will be monitored for side effects and tumor response. The University of Cincinnati Brain Tumor Center is one of five locations in the world participating in this study, which is sponsored by Direct Therapeutics, Inc.

According to Dr. Warnick, eligible participants for either study will receive a careful baseline assessment of their condition by brain tumor experts and regular follow-up medical care. The investigational aspects of these studies are provided at no additional cost to the patient.

To inquire about enrollment and eligibility into these clinical trials, call the Mayfield Clinic at 513-558-3179.