May 15, 2001 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, that is removed after having spread to the lung.
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 cancer in the United States. 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 then treated with dinitrophenyl (DNP), which is a chemical known as a hapten and which modifies them. The altered cells appear foreign enough to the immune system for it to react against them.
In the current study, Dr. Berd and his co-workers gave the vaccine to 37 patients with advanced (stage IV) melanoma that has spread beyond the lymph nodes. Twenty patients had cancer that had spread to the lung. The others had disease spread to other areas. Each had surgery to completely remove the cancer.
Dr. Berd found that giving the DNP vaccine to those patients following their surgery resulted in an estimated 59 percent of patients living three years, which he terms a “good response for these patients.” Only 10 to 20 percent of such patients typically live five years or more with surgery alone.
He reports his team’s results May 14 at the annual meeting of the American Society of Clinical Oncology in San Francisco.
“The unexpected finding is that those with lung metastasis so far are doing better than those with soft tissue metastasis,” says Dr. Berd. “The opposite should be true according to what is published in the medical literature. This goes along with our previous observation that the vaccine is more likely to cause shrinkage of inoperable lung metastases than of skin metastases.”
The researchers also found that nearly all of the patients had a positive immunological skin test called the delayed-type hypersensitivity (DTH) test, indicating an aroused immune system to their own tumor cells following vaccine. Dr. Berd has shown in the past that the patients who had a better DTH response to the modified cancer cells lived longer than those who did not.
Dr. Berd has shown the vaccine to be effective in other trials. In an expanded Phase II trial of 214 melanoma patients with disease spread to either one or two lymph node areas, he reported last year that 47 percent 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 about 20 percent for these patients.
Dr. Berd and his colleagues participate 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 will involve 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, the fifth most common cancer in the nation.
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