Sep. 22, 2009 (PR Newswire) --
OSI-906 in clinical trial for adrenocortical carcinoma
SCOTTSDALE, Ariz., Sept. 22 /PRNewswire-USNewswire/ -- TGen Clinical Research Services at Scottsdale Healthcare today announced the start of a clinical trial for a drug designed to combat adrenocortical carcinoma (ACC), a rare but deadly cancer that attacks the adrenal glands.
TCRS is a strategic alliance between the Translational Genomics Research Institute (TGen) and Scottsdale Healthcare.
Other than surgery, the only treatment for ACC is the exacting use of a compound called mitotane, a chemical relative of DDT, which the U.S. banned as an insecticide in 1972.
TCRS clinicians hope the new compound, OSI-906, developed by OSI Pharmaceuticals Inc. of Melville, N.Y., will stop ACC tumor growth - perhaps even promote tumor shrinkage - without the toxic side effects of current chemotherapies. The trial will focus on patients with inoperable tumors who have relapsed or failed to respond to conventional therapies.
This clinical trial of OSI-906 is expected to last several years and include 135 patients, with 30-40 enrolled at TCRS. As there is no standard therapy available, two-thirds of the patients will receive the drug OSI-906 while one-third receives a placebo. Sites elsewhere in the U.S., as well as in Europe and Australia, are expected to enroll patients over the coming months.
"The trial is major step toward helping patients with ACC, who often face radical surgery as part of their treatment," says Dr. Michael J. Demeure, who will oversee the trial locally. Dr. Demeure is a TGen Senior Investigator and a Scottsdale Healthcare surgeon experienced in removing ACC tumors.
"It's a big operation requiring a large incision because these tumors can be the size of a football. Unfortunately many patients' tumors have spread so we can't remove it all, so new treatments are needed," said Dr. Demeure. "This unique partnership between Scottsdale Healthcare and TGen allows us to bring the newest and most promising treatments to patients with cancer right here in Arizona."
The adrenal glands are responsible for making several critical hormones, including cortisol, which the body needs in order to respond to stress and which helps to maintain normal blood sugar levels in children.
While use of mitotane in ACC patients reduces tumors, it also diminishes adrenal gland function, requiring patients to take hormone replacements for the rest of their lives. In addition, mitotane must be administered for at least three months in order to reach a therapeutic level. Even then, it has proved effective in about 22 percent of ACC cases.
