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New vaccine that inserts a vital gene into a patient’s melanoma cells shows promise against advanced stage disease

A new vaccine for use in patients with advanced melanoma that inserts a vital gene into the patient’s cancer cells shows promise after a 3-year follow-up of trial participants, according to an article in the September issue of the Journal of Clinical Oncology.

Glenn Dranoff, MD, and his American colleagues found that 10 of 35 patients who enrolled in the vaccine study were alive more than 3 years after the trial began and that 4 patients had no sign of disease.

These results, which are comparable to those obtained by Dranoff and his colleagues in earlier studies of similar vaccines that were much harder to work with, suggest the new technique holds real promise as a useful treatment for metastatic melanoma.
"Our findings show that an antitumor immune response to melanoma can be created using a vaccine that is safe and relatively easy to make," says Dranoff, the study’s senior author. "The survival of 10 patients for more than 3 years is especially encouraging and raises the possibility that vaccination might be effective in combination with other, existing therapies."

In the current work, the vaccine was made by removing a portion of a patient’s tumor and mixing the cells with weakened adenovirus particles that carry the gene for granulocyte-macrophage colony-stimulating factor (GM-CSF). As the virus particles invaded the cells, the gene became inserted into the patient’s genome and the tumor cells produced large quantities of the protein. After the tumor cells were injected into the patient, the stimulating factor triggered an immune response that targeted all of the melanoma cells, not merely those carrying the inserted gene.

The study, a Phase I trial, enrolled 35 patients with metastatic melanoma. Vaccines were successfully made for 34 patients. Of the 34 patients, 8 people withdrew from the study because their disease progressed rapidly. Side effects of the treatment were generally minimal, usually consisting of no more than irritation around the injection site.
Researchers removed tumor samples from 16 patients following vaccination to gauge the extent of tumor response. In 10 of those cases, they found a large influx of immune system cells and substantial numbers of dead melanoma cells on microscopic review. In addition, 10 patients ? 29 percent of the original group ? were alive 3 years after receiving the treatment.

The results have encouraged Dranoff and his colleagues to undertake a larger, Phase II study to test whether the vaccine can be effective in patients with melanoma that has not yet metastasized.

"We plan to explore alternative techniques for producing the vaccine, as well as determining which patients can benefit from it the most," Dranoff said. "This will help us determine its proper place in the arsenal of melanoma treatments."



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