Rutgers Cancer Institute of New Jersey is offering a clinical trial examining the investigational treatment known as ONC201 in patients with solid tumors whose cancer no longer responds to standard therapy. The goal of this 'first in human' study is to establish safe dosing levels of the treatment.
Prior research on the study drug conducted by the Cancer Institute of New Jersey and Oncoceutics, Inc. -- which is also supporting this trial -- suggests that ONC201 may be capable of turning off proteins that maintain tumor growth and and may help kill cancer cells while sparing normal ones. Pre-clinical study demonstrated ONC201 was effective in laboratory models against a number of solid tumors including colon cancer, triple-negative breast cancer and non-small cell lung cancer.
Mark Stein, MD, medical oncologist at the Cancer Institute and assistant professor of medicine at Rutgers Robert Wood Johnson Medical School, is the lead investigator on the study. "By exploring a novel agent that targets the cancer but leaves non-cancerous tissue untouched, we have an opportunity to not only provide a new treatment option for patients who have exhausted standard forms of therapy, but to also offer them a therapeutic that may result in a better quality of life since healthy cells are not impacted," he said.
"As a National Cancer Institute-designated Comprehensive Cancer Center, it is part of our mission to bring novel therapeutics to clinical practice. With that, we are pleased to be the first clinical site to offer ONC201 to patients in need of new therapies," said Chief Surgical Officer Howard L. Kaufman, MD, FACS, who is also the associate director for clinical science at the Cancer Institute and a professor of surgery at Robert Wood Johnson Medical School.
Individuals aged 18 and older who are diagnosed with a solid tumor (not involving blood, bone marrow or lymph nodes) for which commonly used treatments no longer work 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. Accepted patients will receive two doses (cycles) of ONC201 in pill form by mouth every 21 days. After the second cycle, patients will be evaluated for up to four weeks.
For more information on how to take part in this trial, individuals should call the Cancer Institute's Office of Human Research Services at 732-235-8675 or e-mail email@example.com.
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.
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