New clinical trial uses aggressive treatment method for patients with pancreas cancer

Pancreas cancer remains one of the deadliest cancers worldwide. In the United States, it accounts for only three percent of all diagnosed cancers but it causes almost seven percent of all cancer deaths. A pancreas cancer diagnosis often comes after age 50 and after the cancer has spread, making it difficult to remove surgically. A new clinical trial that recently opened at the University of New Mexico Comprehensive Cancer Center may help more people to undergo surgery to remove their pancreas tumors. And that may help more of them to live longer.

According to Itzhak Nir, MD, at the UNM Comprehensive Cancer Center, surgically removing the tumors is the only way to cure pancreas cancer. Nir specializes in cancers of the liver, pancreas and other digestive system organs. He says, "Only 20 percent of patients ever make it to surgery, which is the only way to cure someone of this cancer." And, he says that fewer than five percent of people whose tumors cannot be removed surgically survive for five years or more.

The new clinical trial uses an aggressive treatment approach. "This clinical trial utilizes some of the best aspects of what we've learned so far with chemotherapy and radiation," says Gregory Gan, MD, PhD. "It combines these with a new and exciting therapy called immunotherapy — a treatment which harnesses the body's immune system to help with fighting cancer." Gan specializes in radiation oncology and serves as the trial's principal investigator at UNM Cancer Center.

"This clinical trial uses innovative therapies and a unique approach," says Olivier Rixe, MD, PhD. Rixe oversees all clinical trials at UNM Cancer Center. He says, "We are one of the few centers to offer this clinical trial and one of very few centers that can combine the technologies that this trial requires."

Currently, UNM is the only site in the Southwest and Rocky Mountain area to offer this trial. In New Mexico, the trial is conducted in partnership with the New Mexico Cancer Care Alliance. Only a few other academic medical centers offer the trial nationwide.

The trial combines the potent chemotherapy regimen FOLFIRINOX and pinpoint-accurate stereotactic body radiation treatment with an immunotherapy drug called algenpantucel-L from NewLink Genetics. FOLFIRINOX and stereotactic body radiation have been studied separately and the studies showed that each helped people with pancreas cancer become candidates for surgery. The clinical trial's strategy uses all three treatments to shrink pancreas tumors enough to make surgery possible for more people.

Previous studies have shown FOLFIRINOX to shrink pancreas tumors prior to surgery. It's used routinely for metastatic pancreas cancer. Stereotactic body radiation is a newer type of radiation therapy which delivers higher doses of radiation to the tumor but spares the surrounding tissue. "This technology [stereotactic body radiation] has been used successfully in both primary and metastatic lung and liver cancers, notably for patients who could not otherwise undergo surgery, with local control rates in excess of 90 percent" says Gan.

The experimental drug algenpantucel-L trains the immune system to recognize pancreas cancer cells. It consists of dead, genetically modified pancreas cancer cells. "The genetic changes in these cells lead to protein changes on the cells' surface which make them an excellent target for a person's immune system to react to," says Gan. And because the immune system learns to recognize pancreas cancer cells, the drug may control tumors for a very long time.

"The hope is that the combination of the most potent chemotherapy, radiation therapy, and immunotherapy will help make patients who were previously considered non-surgical able to undergo curative surgery," says Gan. "This trial combines the best of what we know."