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Rutgers Cancer Institute of New Jersey is One of Several Worldwide Sites to Offer PROSTVAC Clinical Trial

Study examines vaccine-based treatment for prostate cancer
September 17, 2014

Mark Stein, MDNew Brunswick, N.J. – Rutgers Cancer Institute of New Jersey is one of several worldwide sites to offer a clinical trial examining the investigational vaccine-based treatment PROSTVAC in patients with prostate cancer that is no longer responsive to hormone therapy and has spread (metastasized) to other parts of the body. The goal of this immunotherapy study is to see if PROSTVAC improves survival when combined with a drug that helps boost the body’s ability to fight infection. 

Results from a previous clinical trial at the Cancer Institute of New Jersey (published in the January 3, 2006 edition of the Journal of Translational Medicine) that examined two forms of PROSTVAC gave researchers information on the safety of using this investigational drug.  This new study will further explore PROSTVAC and examine how well it does in improving survival outcome for metastatic prostate cancer patients.  PROSTVAC-V is derived from a vaccinia virus that was used for many years to vaccinate against smallpox.  PROSTVAC-F is made from the fowlpox virus, which is found in birds and not known to cause any human disease.  Needle injections of both forms of PROSTVAC will be given to some participants. 

Some participants also will be given needle injections of a drug called GM-CSF along with PROSTVAC.  GM-CSF is a protein normally made by the body to increase the amount of certain white blood cells and make them more active. When in drug form, it is used to boost the body’s immune system to fight off disease. GM-CSF is already approved by the United States Food and Drug Administration for post-chemotherapy treatment of some cancer patients to help them increase their white blood cell production.

Patients accepted into the study will be selected at random to receive PROSTVAC plus GM-CSF, PROSTVAC plus a GM-CSF placebo, or a PROSTVAC placebo and a GM-CSF placebo.  Participants will take part in the treatment for approximately five months and will undergo study follow-up that includes questionnaires and brief physical exams for approximately five years.

Mark Stein, MD, medical oncologist at the Cancer Institute and assistant professor of medicine at the Rutgers Robert Wood Johnson Medical School, is the lead Cancer Institute physician-scientist on the new study.  “By further exploring drugs that can increase the body’s natural defenses to potentially slow or halt cancer metastasis, we have an opportunity to offer patients with metastatic disease new treatment options,” he said.

Men aged 18 and older who are diagnosed with metastatic castration-resistant prostate cancer are eligible to take part in the trial, although other criteria must also be met.  Prior to being accepted into the study, participants would be required to undergo a number of tests including blood work and a physical exam. 

For more information on how to take part in this trial, which is sponsored by BN ImmunoTherapeutics, Inc., individuals should call the Cancer Institute’s Office of Human Research Services at 732-235-8675 or e-mail cinjclinicaltrials@cinj.rutgers.edu.  

Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer.  At the Cancer Institute, 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 the Cancer Institute, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether they are 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, the Cancer Institute offers patients access to treatment options not available at other institutions within the state.  The Cancer Institute currently enrolls more than 1,200 patients in clinical trials annually, including approximately 17 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 Rutgers Cancer Institute of New Jersey
Rutgers Cancer Institute of New Jersey (www.cinj.org) is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center. As part of Rutgers, The State University of New Jersey, the Cancer Institute of New Jersey is dedicated to improving the detection, treatment and care of patients with cancer, and to serving as an education resource for cancer prevention. Physician-scientists at the Cancer Institute 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 the Cancer Institute of New Jersey, call 732-235-8614 or visit www.cinj.org/giving. Follow us on Facebook at www.facebook.com/TheCINJ.

The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides the highest quality cancer care and rapid dissemination of important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. System Partner: Meridian Health (Jersey Shore University Medical Center, Ocean Medical Center, Riverview Medical Center, Southern Ocean Medical Center, and Bayshore Community Hospital). Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Medical Center, Carol G. Simon Cancer Center at Overlook Medical Center, and Cooper University Hospital. Affiliate Hospitals: JFK Medical Center, Robert Wood Johnson University Hospital Hamilton (CINJ Hamilton), Robert Wood Johnson University Hospital Somerset, and University Medical Center of Princeton at Plainsboro.

 

Contact: 
Michele Fisher
Phone: 
732-235-9872

 

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