January 6, 1998

Media Contacts: Sarah Goodwin, 404/727-3366 - sgoodwi@emory.edu
Kath i Ovnic, 404/727-9371 - covnic@emory.edu

Emory cancer researchers are conducting clinical trials of a method of drug delivery that appears to dramatically increase the effec ts of traditional chemotherapeutic drugs on brain cancer.

Mark Gilbert, M.D., associate professor of neurology and co-director of the Brain Tumor Center at the Winship Cancer Center of Emory University, helped develop the principle of a more prolonged exposure to the drug and is one of the primary investigators in this 30-site national trial.

Patients taking part in the study return to Emory University Hospital within four weeks after having surgery. They then begin 72 hours of c ontinuous chemotherapy, a process they will go through once a month for three months. After these intensive chemotherapy treatments are completed, the patients begin external radiation therapy.

"The problem with traditional chemotherapy, which is done on an outpatient basis, is that the drugs disperse in the bloodstream in about 15 minutes," Dr. Gilbert says. "An outpatient chemotherapy session lasts one to two hours. If it takes an hour for the drugs to make it to the brain, such a smal l amount of medication reaches the tumor site that it does not make much of an impact."

Dr. Gilbert also says the blood-brain barrier, the lining of the brain that protects it from poisons in the bloodstream, tends to further lessen the amount of drug that makes it to the remaining cancer cells. With continuous chemotherapy, the drug has time to get to the brain, penetrate the blood-brain barrier and reach the cancer.

Previous trials of the protocol have shown great promise in patien ts with malignant gliomas, or advanced brain tumors. This type of cancer includes glioblastoma multiforme, the most common and most serious form of adult brain tumor. These patients do not normally respond well to chemotherapy given over a short interva l, and the average survival rate after diagnosis is less than one year.

Phase I and II trials of the drug protocol tested the safety and efficacy of the drug. The current Emory study is a Phase III trial, conducted under the auspices of the E astern Cooperative Oncology Group (ECOG), which will compare the results of the protocol with those of methods currently in use.

"The outcomes from the Phase I and II trials were very encouraging," Dr. Gilbert says. "We have patients from th ose trials who are still doing well after seven years. The Phase III study has been underway for two years here at Emory, and preliminary results look as though the protocol is having a positive impact on patients enrolled in the study."

Curren tly more than 90 patients have taken part in the study, and researchers hope to enroll a total of 220 volunteers to complete their investigation. Participants must be newly diagnosed with a glioblastoma multiforme and must not have had radiation or any o ther kind of therapy. For more information on the trial, call Terri Armstrong, neuro-oncology nurse practitioner, at (404) 778-2180.


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