Researchers at The Cancer Center at Hackensack University Medical Center are participating in a phase III clinical trial to test the safety and effectiveness of a drug called Allovectin-7® to treat advanced melanoma that has spread beyond the original site (stage III or IV melanoma). If successful, Allovectin-7® may offer patients a new treatment option to prolong their lives.

If it is detected early, melanoma can often be cured by surgery. But when it has advanced to stage III or IV, it cannot be cured. Treatment at this stage is focused on shrinking the tumor and increasing a patient’s length of survival. The current standard treatment used for stage III or IV melanoma is chemotherapy, but sometimes it does not induce a response in patients and it can cause side effects.

“This study will help us to determine whether using Allovectin-7® alone will be more effective than using chemotherapy alone to treat the melanoma,” says hematologist/oncologist Robert S. Alter, M.D., chief of the Division of Head and Neck Oncology at The Cancer Center, who is heading the trial. “Phase II trials among 700 patients in several cancer centers already proved that Allovectin-7® was safe, effective, and less toxic to patients than chemotherapy. With this phase III trial, we are studying a larger number of patients nationwide.”

Allovectin-7® is a type of cancer treatment called a biotherapy. Allovectin-7® helps train the body’s immune system to locate and eliminate cancer cells without harming normal ones. It is injected into a lymph node weekly for six consecutive weeks. The injection cycle may be repeated every eight weeks.

“We believe that Allovectin-7® triggers several of the body’s natural immune response mechanisms to recognize and attack the tumors, both locally and throughout the body,” explains Dr. Alter, who works closely with the Division of Sarcoma and Skin Cancer in treating patients with melanoma.

To be eligible for this study, patients must be at least 18 years old and meet certain criteria. Sixty-seven percent of patients enrolled in the trial will be randomly assigned to receive Allovectin-7®, and 33 percent will receive chemotherapy. Patients will be carefully monitored throughout the study. Those on Allovectin-7® whose melanoma does not progress will be encouraged to continue on the trial indefinitely.

“With this Allovectin-7® trial, we join with major institutions such as New York Hospital-Columbia University Medical Center to bring cutting-edge research and treatments directly to our patients with melanoma, offering them a therapy that may extend their lives and offer them more time to spend with their loved ones,” says Andrew L. Pecora, M.D., chairman and executive administrative director of The Cancer Center at Hackensack University Medical Center. “This is another example of the extraordinary cancer care we provide here that gives our patients access to the most advanced treatments possible.”

Within the Division of Sarcoma and Skin Cancer at The Cancer Center at Hackensack University Medical Center, a team of skin cancer specialists is dedicated to diagnosing, treating, and managing all types of skin cancer, including melanoma. Innovative treatments for melanoma that are currently being investigated in clinical trials at The Cancer Center include vaccines that stimulate the immune system to fight the cancer and combinations of chemotherapy, gene therapy, and hormonal therapy that use genes that have been altered to destroy cancer cells.

The Cancer Center at Hackensack University Medical Center is New Jersey’s largest and the one ranked the best cancer center in the state by New York magazine. The Cancer Center focuses on transforming cancer care by offering multidisciplinary care, personalized treatment, innovative research, superior outcomes, and patient satisfaction within 14 disease-specific, treatment, or research divisions.