Looking to harness the body’s own immune system to target prostate cancer that has spread to the bones (metastatic) and is unresponsive to standard treatment, investigators at The Cancer Institute of New Jersey (CINJ) have just launched a clinical trial focusing on a combination of vaccine and radiation drug therapy. The goal is to see if disease progression will be further delayed by adding two different experimental injections to the standard treatment. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

A standard treatment for prostate cancer that has spread to the bones is with a drug approved by the Food and Drug Administration known as samarium153. It contains material that gives off a tiny amount of energy (radiation) that damages cancer cells. And because radiation drugs such as samarium153 also can increase the immune system’s ability to find and kill cancer cells, CINJ researchers want to combine this treatment with a series of vaccination injections aimed at helping the body’s natural defenses work better.

At focus are two different experimental vaccines. PROSTVAC-V/TRICOM has a special virus added to it that produces a prostate specific antigen (PSA) protein which helps focus the body’s immune response to the PSA in the prostate tumor.

Other human genetic material added to this vaccine produces three other proteins that help increase an immune cell’s ability to destroy its target. The second vaccine, PROSTVAC-F, contains the same genetic material as PROSTAC-V, but will be given more frequently to boost the body’s immune system. Previous studies led by CINJ Director Robert S. DiPaola, MD, professor of medicine at UMDNJ-Robert Wood Johnson Medical School, have shown that giving the PROSTVAC-V vaccine followed a short time later by booster injections with PROSTVAC-F is more effective in increasing immune response than receiving one vaccine alone.

Mark Stein, MD, medical oncologist at CINJ and assistant professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead researcher on the new study. “Naturally, the body’s immune system is designed to fight off foreign material, but falls short when it comes to recognizing cancer cells. Through this combination of radiation therapy and vaccine injections, we’re trying to create a better ‘bull’s-eye’ for the body to target by utilizing more of the body’s own natural materials,” he said.

Adults with metastatic prostate cancer resulting in bone lesions that are not responding to standard treatment are eligible to take part in the trial, although other criteria must be met. Prior to being accepted into the study, participants would undergo a number of tests including blood work, a bone scan and a physical.

If accepted for participation in the trial, individuals will be divided at random into two groups for treatment. Those receiving samarium153 by itself will receive the drug by vein. Those selected for the combination therapy will receive samarium153 as well as one injection of PROSTAC-V/TRICOM in the thigh and then monthly injections of PROSTAC-F/TRICOM under the skin during the course of the study. After four months on study, participants will be evaluated for how the cancer is responding to treatment and continue to be treated with the assigned treatment regimen if the disease is responding favorably and they are not having severe side effects.

Following completion of treatment, participants will be monitored for 15 years. They will be required to undergo an annual exam for five years and answer questions about their health. For the remaining ten years, participants will be asked to answer health questions once a year by phone.

For more information on how to take part, individuals should call CINJ’s Office of Human Research Services at 732-235-8675 or e-mail .(JavaScript must be enabled to view this email address).

The trial is sponsored by the National Cancer Institute through the Cancer Therapy Evaluation Program.

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 has more than 1,000 patients enrolled in 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.

About The Cancer Institute of New Jersey
The Cancer Institute of New Jersey (http://www.cinj.org) is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center dedicated to improving the detection, treatment and care of patients with cancer, and serving as an education resource for cancer prevention. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. To make a tax-deductible gift to support CINJ, call 732-235-8614 or visit http://www.cinjfoundation.org. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

The CINJ Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, Cooper University Hospital and Jersey Shore University Medical Center. Affiliate Hospitals: Bayshore Community Hospital, CentraState Healthcare System, JFK Medical Center, Mountainside Hospital, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter’s University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton.

Source:  Cancer Institute of New Jersey