Researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial to evaluate whether the standard treatment for a common form of kidney cancer works better by itself or when combined with a certain type of blood cell that comes from a patient's relative. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

The Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients with Renal Cell Carcinoma -- or SPECIAL -- trial is sponsored by the United States Food and Drug Administration, which also will monitor the study. It will look at patients with renal cell carcinoma that has spread to other parts of the body (metastatic), who are currently being treated with the drug sunitinib. According to the American Cancer Society, the lifetime risk of developing kidney cancer is one in 75, and nine in ten cases are renal cell carcinoma.

Doctors at CINJ previously developed a treatment for the disease, transferring a type of white blood cell (immune cell) from a relative into the patient's body through a blood transfusion in an effort to kill renal cancer cells. In an earlier study, several patients with metastatic renal cell carcinoma who received the new therapy had shrinkage in their tumors. Investigators want to see if combining sunitinib with these immune cells will work better than if the drug was given by itself.

Roger Strair, MD, PhD, director of the Hematologic Malignancies Program at CINJ and professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead investigator of the new study. "There have been a number of new drugs in recent years to treat metastatic kidney cancer, but for many patients receiving these new drugs the tumor does not shrink, or it grows back after it shrinks. We are doing a clinical trial to determine if combining immune cells from the natural defense system of a relative with these new drugs results in a better anti-cancer response rate," he said.

Before taking part in the trial, interested participants and select family members will undergo blood tests to determine if that relative can donate immune cells. Selected patients with metastatic kidney cancer will take sunitinib by mouth once a day for four weeks followed by a two-week rest period (a cycle). The cycle will repeat until serious side effects are noted or the disease progresses. Participants also will undergo blood transfusions from their relative every eight weeks and will have image scan testing throughout the trial period. Following completion of the study, participants will receive periodic check-ups for several years.

Anyone at or over age 18 who has been diagnosed with metastatic renal cell carcinoma and has a blood relative willing to give immune cells may be eligible to take part in the trial, although other criteria must also be met. For more information on how to take part in the SPECIAL trial, individuals should call CINJ's Office of Human Research Services at 732-235-8675.

Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. At CINJ, researchers use these studies to answer questions about how a treatment affects the human body and to make sure it is safe and effective. There are several types of clinical trials that are currently underway at CINJ, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether it is drugs or vaccines; ways to do surgery or give radiation therapy; or combinations of treatments, are the results of past clinical trials.

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, CINJ offers patients access to treatment options not available at other institutions within the state. CINJ currently enrolls more than 1,000 patients on clinical trials, including approximately 15 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in these studies nationwide is fewer than five percent of all adult cancer patients.

The Cancer Institute of New Jersey

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