BACKGROUND: For thousands of patients with brain tumors, managing the side effects of treatment is half the battle. Many patients must take steroids, like dexamethasone, to reduce the swelling in their brains. Without these potent drugs, the swelling around the tumor can cause neurological problems. Nick Avgeropoulos, M.D., a nuero-oncologist from Florida Hospital Cancer Institute in Orlando, says: "The swelling can sometimes cause a much worse deficit than the tumor does by itself. Steroids work very well at suppressing the swelling, in general, but the problem is, over time, steroids can carry a lot of side effects." Some of those side effects include: » Insomnia » Psychosis » Blood pressure and blood sugar irregularities » Weight gain » Muscle weakness A NEW OPTION: Now, researchers are testing an alternative to steroids to reduce brain swelling. The new agent is called h-CRF, or human corticotrophin releasing factor. It is injected two times a day. The therapy works by helping the body stimulate its own steroids. "For so long, the body has been exposed to steroids in a pill form, and the body, many times, forgets how to make it, so it stimulates it but without all of the adverse events and with a more pure and natural way of using the body's own mechanism to replace and get back to normal," says Dr. Avgeropoulos. THE STUDY: Researchers are currently analyzing the data from Phase II of the study, but they say the results look very encouraging. "We have had pretty much, across the board, very good results with some dramatic results," says Dr. Avgeropoulos. Right now, researchers are testing the drug on the most needy patient population. Researchers are enrolling patients for Phase III of the clinical trial at about 35 centers around the country. For a list of those centers, go to http://www.clinicaltrials.gov/ct/show/NCT00088166?order=3 THE QUALITY OF LIFE FACTOR: Dr. Avgeropoulos says one of the unique and important aspects of this clinical trial is that the new drug is helping patients' quality of life. Many have been able to get off steroids and avoid the harsh side effects the drugs pose. "We know that even if a therapy does not necessarily improve the quantity of life, if that quality of life is 90 percent instead of 10 percent, well we have done something, and we have done something affirmative, positive and good for our patients," says Dr. Avgeropoulos. OTHER APPLICATIONS? Although h-CRF isn't being used to help patients with other disorders right now, Dr. Avgeropoulos says it very well may be studied for rheumatologic conditions like lupus in the future.
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