Editor's Note: 6/7/00: The following trial is closed now - we are awaiting published results!

BRAIN TUMOR PATIENTS OFFERED NEW HOPE WITH EXPANDED TRIAL OF PROMISING THERAPY

UPTON, NY - Brain tumor patients, including those whose cancer is inoperable or has regrown, may find new hope in an expanded clinical trial of a promising experimental therapy offered by the U.S. Department of Energy's Brookhaven National Laboratory.

BNL and its collaborating institutions are seeking 56 patients with the lethal type of brain cancer known as glioblastoma multiforme to participate in the new clinical trial begun recently.

Already, clinical trials at BNL have yielded preliminary results indicating that the enhanced-radiation treatment, called boron neutron capture therapy or BNCT, may give patients a better quality of life than conventional treatments do, while offering similar life expectancy and causing few side effects. And, BNCT's treatment time is much shorter than that of other therapies.

Since the start of its clinical trials in 1994, BNL has been the one of only three institutions in the world offering BNCT for brain tumors. The new trial will increase the radiation dose aimed at the tumor, and expand eligibility requirements for patients diagnosed with glioblastoma multiforme.

Among those now able to participate in the trial are patients whose tumor has begun to grow again, despite previous treatment with radiation or chemotherapy. Such patients often cannot tolerate other therapies aimed at killing the tumor, and most die within three months.

Patients whose tumors cannot be removed by surgery will also be eligible.

"With this trial, we're offering a new option to those who need it most, while continuing to improve BNCT and include more patients," said Jeffrey Coderre, leader of the BNL team.

BNL's partners in the trial are the State University of New York at Stony Brook's Health Sciences Center and Beth Israel Medical Center in Manhattan, and the University of Tennessee at Knoxville. "Together, this network of physicians and researchers will give patients from New York and around the nation the choice of being treated with BNCT," said Coderre.

Prospective patients, their family members or their physicians should call 516-344-3684, or visit http://www.bnct.bnl.gov on the World Wide Web, for more information.

Enhanced Radiation To Kill Cancer Cells

BNCT is a two-part therapy that enhances the effect of radiation on cancer cells while minimizing the effect on nearby healthy cells.

So far, BNL has treated 41 patients diagnosed with glioblastoma multiforme, which strikes more than 7,000 Americans each year. The disease is usually treated with surgery, followed by conventional radiation alone or in combination with chemotherapy.

For glioblastoma patients, as well as other cancer victims, damage to non-cancerous tissue is a major side effect of conventional radiation therapies.

Conventional radiation therapy also requires as many as 30 sessions of treatment, an inconvenience for many patients - especially those with a fatal diagnosis. And both radiation and chemotherapy result in many side effects, including hair loss and crippling nausea.

Even after conventional treatment, spidery extensions of the main tumor can evade destruction, surviving and growing again, and eventually killing the patient.

BNCT is designed to avoid many of these pitfalls. It uses radiation from the Brookhaven Medical Research Reactor and a drug containing the element boron called BPA for borono-phenylalanine. The drug is injected into the patient intravenously and travels through the bloodstream, concentrating preferentially in tumor tissue.

By itself BPA is harmless, but when exposed to a beam of neutrons from the reactor, the boron atoms "capture" neutrons, creating secondary effects that kill cells in the immediate vicinity. The surrounding healthy brain tissue is left relatively unharmed. The treatment can be delivered in a single session and causes virtually no side effects.

While BNL's clinical trial has focused on brain tumors, BNCT may eventually work for many other kinds of cancer. Research is now under way at Brookhaven and elsewhere to expand the range of diagnoses on which BNCT could be used.

Expanded Entry Requirements

BNCT's unique strategy has shown promise in destroying tumor tissue from within. But the experimental nature of the therapy has required carefully selected conditions for the trial.

Until now, all BNCT patients have first had to undergo surgery to remove the bulk of their tumors, and the strict requirements for tumor size, depth and placement have limited the number of patients participating. Relatively low doses of radiation have been used.

The new trial will allow more patients to participate and will increase the radiation dose. One group of patients will receive a one-time escalated dose, while another will receive a lesser dose in two "fractions" spread over two days.

A third group will be able to receive BNCT without having had surgery. This will allow BNL to treat patients whose tumors are too close to crucial brain centers to be removed. This group may include more patients over the age of 65, who often elect to forego surgery. BNL's BNCT trials have already shown that patients over 65 experience a somewhat increased life expectancy than with conventional treatments.

The fourth group will include those who have already had BNCT or conventional therapy once, but whose tumor has begun to regrow from tumor cells left behind by the previous treatment. The time since last treatment must be at least six months.

To be accepted into the BNL trial, patients must have a confirmed diagnosis of glioblastoma multiforme and must be over 18.

The U.S. Department of Energy's Brookhaven National Laboratory creates and operates major facilities available to university, industrial and government personnel for basic and applied research in the physical, biomedical and environmental sciences, and in selected energy technologies. The Laboratory is operated by Brookhaven Science Associates, a not-for -profit research management company, under contract with the U.S. Department of Energy. **************************************
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