Vaccine Against Melanoma Proves Successful For Patients With Disease Spread To Two Lymph Node Areas

April 13, 1999

A custom-made vaccine created from a patient's own cancer tumor cells appears effective in prolonging the survival of patients with malignant melanoma, the deadliest form of the skin cancer, spread to two lymph node areas.

David Berd, professor of medicine at Jefferson Medical College of Thomas Jefferson University in Philadelphia and a member of Jefferson's Kimmel Cancer Center, and his colleagues had previously proven the effectiveness of the vaccine in treating patients with malignant melanoma. Now, the researchers treated a subset of the original group of patients who had a particularly poor prognosis. Each had cancer that had spread to two lymph node areas, and each had surgery to remove the visible disease. The patients were then given the vaccine. According to Dr. Berd, 39 percent are estimated to live three years. In general, he says, only some 5 to 15 percent of such patients are cured by surgery alone.

In 15 patients with melanoma spread to the pelvic lymph nodes, 47 percent are estimated to live five-years. The usual surgical cure rate is only 5 to 10 percent.

"Now we're looking at a group of patients with a particularly bad prognosis, and our results strengthen the evidence that the vaccine is therapeutic in a critical situation," says Dr. Berd.

He reports his results April 13 at the American Association for Cancer Research meeting in Philadelphia.

The vaccine is termed autologous, meaning that it's prepared from a patient's own cancer cells. Before injecting the cells into patients, the cells are inactivated and treated with a chemical, dinitrophenyl (DNP), which chemically modifies them. The modified cells appear foreign enough to the body's immune system for it to react against them.

In the June 1997 issue of the Journal of Clinical Oncology, Dr. Berd reported the results of treatments on patients with melanoma spread to a single lymph node site (stage III disease). The vaccine treatments were started after the lymph nodes had been removed. Of 62 patients, 36 were still alive after a median follow-up time of 55 months. The projected 5-year relapse-free and overall survival rates for these patients were 45 percent and 58 percent respectively. This compares favorably with the 15- to 25-percent survival rates reported in patients treated with surgery alone.

Dr. Berd and his colleagues currently are participating in a Phase III trial to test the effectiveness of the vaccine on patients with disease that has spread to the lymph nodes. AVAX Technologies, Inc., of Kansas City, MO--which has exclusive rights to the Jefferson-based vaccine against malignant melanoma--sponsors the trial. AVAX is building a new vaccine laboratory and manufacturing facility in Philadelphia to increase quantities of the vaccine for future testing and use. The five-year randomized trial, already underway, will compare the effectiveness of an autologous melanoma vaccine to the standard treatment, which is alpha interferon. The trial involves 400 patients seen at institutions in several major cities. If the trial is successful, then AVAX will ask the FDA for approval to allow it to market the vaccine.

Malignant melanoma is the fastest growing cancer in the United States and is the fifth most common cancer among Americans. According to the American Cancer Society, more than 40,000 new cases will be diagnosed in 1999; more than 7,000 Americans will die from the disease.

Thomas Jefferson University

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