News Release

Vaccine against melanoma proves successful for patients with disease spread

Peer-Reviewed Publication

Thomas Jefferson University

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.

David Berd, M.D., 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 shown the vaccine was effective in treating patients with malignant melanoma, the fastest growing - and fifth most common - cancer in the United States.

Now, Dr. Berd reports that in an expanded Phase II trial of 214 melanoma patients with disease spread to either one or two lymph node areas, 47 percent have lived for five years. Those with cancer spread to only one lymph node area did even better (50 percent five-year survival). The surgical cure rate is 20 percent for these patients. The longest follow-up time is now more than 10 years.

He reports his results May 22 at the American Society of Clinical Oncology meeting in New Orleans.

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 dinitrophenyl (DNP), which is a chemical known as a hapten and which modifies them. The altered cells appear foreign enough to the body's immune system for it to react against them.

According to Dr. Berd, his team also confirmed an earlier finding indicating the value of an immunological skin test called the delayed-type hypersensitivity (DTH) test. In 1997, Dr. Berd reported that the patients who had a better positive DTH - indicating an aroused immune system - to their own tumor cells following vaccine live longer than those who did not. In fact, those who developed a response had a five-year survival rate of 65 percent versus 32 percent for those who had no response.

"One of the problems in the field is that there isn't a test for the efficacy of vaccines," he says. "We give the test before the two month vaccine treatment and after. Only 40 to 50 percent develop the response, but those who do live longer. We think it's a way of figuring out if the vaccine works." Dr. Berd also points out another fact: most patients who do well with the vaccine after two years have a good chance of living five years or more. "Those who are doing well after two or three years have a very good chance of long-term survival," he says.

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 five-year relapse-free and overall survival rates for these patients were 45 percent and 58 percent respectively.

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. The five-year randomized trial compares the effectiveness of the melanoma vaccine to the standard treatment, which is alpha interferon. The trial involves approximately 400 patients seen at institutions in several major cities.

More than 40,000 new cases and 7,000 deaths will occur this year from the disease.

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Contact: Steve Benowitz or Phyllis Fisher
215/955-6300
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Editors: This information is embargoed for release May 22 at 1 p.m. EST at the American Society of Clinical Oncology meeting in New Orleans


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