Trial looks at new treatment for solid cancer tumors and non-Hodgkin's lymphoma

Researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial, which aims to evaluate a new treatment for solid cancer tumors and non-Hodgkin's lymphoma (NHL) in combination with a chemotherapy agent called cyclophosphamide.

CINJ is a center of excellence of UMDNJ-Robert Wood Johnson Medical School.

This trial, sponsored by the National Cancer Institute, is combining the experimental drug ABT-888, an agent which targets DNA repair with the FDA-approved drug cyclophosphamide. ABT-888 is part of a new class of drugs, known as poly (ADP-ribose) polymerase (PARP) inhibitors. Cyclophosphamide kills cancer cells by damaging the materials that makes up one's genes. This material (DNA) allows cancer cells to survive and reproduce. One's body has certain proteins that try to help repair DNA damage. ABT-888 may prevent such repair so that cyclophosphamide can kill more cancer cells, than if cyclophosphamide were given alone.

Antoinette R. Tan, MD, a medical oncologist at CINJ and assistant professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead investigator of the study. She notes, “ABT-888 blocks enzymes that repair DNA damage. The addition of this investigational agent affects the DNA repair process and in essence, helps cyclophosphamide, a DNA-damaging drug, do its job. Because cyclophosphamide is used in the treatment of several types of cancer, this new treatment combination could have implications across a wide spectrum. In particular, cell lines with BRCA mutations have been shown to be sensitive to PARP inhibitors, so this treatment may hold promise for metastatic patients with BRCA mutations.”

Before taking part in the trial, interested participants will undergo various examinations including a general physical and routine blood and urine tests. Selected patients will take ABT-888 by mouth and cyclophosphamide through a vein for a three-week cycle. Participants also will keep a medication diary and continue with standard testing such as blood work and physical exams throughout the trial period. If it is deemed the patient is having a positive response to the drug combination, the patient will have the option to continue with that course of treatment for the remainder of the study, which is expected to take two years to complete.

Men and women at or over age 18, who have non-Hodgkin's lymphoma, or a solid tumor that has spread to another area which has not responded to standard treatment, or a type of cancer in which standard treatment does not exist, are eligible to take part in the trial, although other criteria must be met. For more information on how to take part, 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.