International study finds new agent for treating recurrent brain tumors
Contact: Jennifer Hart, (713) 792-3457; [email protected]
DENVER--An international study has found a new agent that may prove useful for treating patients with an aggressive brain tumor known as anaplastic astrocytoma.
Each patient in the study was given oral Temodal for five consecutive days, with the regimen of treatment being repeated every 28 days. The patients' progress was reviewed every two months using magnetic resonance imaging scans.
Conducted in the United States, France and Great Britain, the study found a significant number of patients experienced brain tumor reduction when given Temodal. More than 42 percent of the 161 study participants treated with the drug experienced a significant reduction in tumor size.
The clinical trial may result in U.S. Food and Drug Administration approval for Temodal in treating patients with anaplastic astrocytoma.
The study, conducted at 32 institutions in the three countries, was led by Dr. Victor Levin, chairman of the Department of Neuro-Oncology at The University of Texas M. D. Anderson Cancer Center in Houston. Results were reported Monday at the 33rd annual meeting of the American Society of Clinical Oncology in Denver, Colo.
"The study is very encouraging because there are few treatments available for this very aggressive type of brain tumor," said Dr. Levin. "The patients in the study tolerated the drug very well, too, with no negative impact on their quality of life."
More than 5,000 people in the United States annually are diagnosed with anaplastic astrocytoma, the second most common form of brain tumor in adults. The death rate from the disease is about 80 percent, with a median length of survival following diagnosis of about three years.
"Our conclusion is that Temodal is an effective treatment for patients with this particular form of brain tumor," said Dr. Levin. "Consequently, we believe the drug is worthy of approval by the Food and Drug Administration."
Dr. Levin pointed out that the possibility of Temodal obtaining FDA approval is "very exciting because it would be only the third brain tumor drug approved by the FDA since the 1960s." He added that once the drug is approved by the FDA, it most likely will be used in combination with other agents for treating patients with anaplastic astrocytoma.
Temodal is produced and developed by the Schering-Plough pharmaceutical company.
- 30 -
RSS