GMU researchers hope to customize breast cancer treatment

By Jennifer Buske
Washington Post Staff Writer
Sunday, February 21, 2010

The technology is produced, the research is done, and now two professors from George Mason University's Prince William County campus are trying to bring their findings to the bedside.

With the help of grant money, Lance Liotta and Emanuel Petricoin launched a clinical trial last week to study whether medical professionals can customize treatment for patients with metastatic breast cancer by looking at the protein pathways that vary inside each tumor.

"This breast cancer trial is the first of its kind and probably the most cutting-edge clinical trial in the U.S. right now, perhaps the world, in terms of breast cancer," Petricoin said. "Five to 10 years ago, we viewed all breast cancer as the same, but the truth is most patients' [tumors] are not alike."

Liotta and Petricoin, who joined Mason in 2005, have spent the past decade studying how to personalize cancer treatment. Because most drug treatments target deranged and activated protein pathways in cells, the duo developed technology that determines which protein pathways are active in an individual's cell. Once medical professionals can pinpoint the active zone, they can select which medication approved by the U.S. Food and Drug Administration will best treat a patient's cancer, the professors said.

"What we get out of the technology is a road map of the inside of a cell, so we can see the vulnerable areas," said Liotta, 62. "It's like an electrician testing a circuit to see where the problems are."

Although the professors are doing a somewhat similar colorectal cancer trial with one drug -- Gleevec, normally used for leukemia treatment -- this is the first large-scale personalized therapy trial in which the protein pathways are used to guide therapy choice, Petricoin said. In the past, research and treatment methods looked at only the genetic makeup of a cell and where it was located.

"It's not about where the cancer is located; it's about the molecular fingerprint," said Petricoin, 45. "And . . . we've learned that every patient's tumor is different at a molecular level, so it's no wonder why drugs don't always work for every person."

The clinical trial is being funded with the help of Side-Out Foundation, a nonprofit group based in Virginia. Because of non-disclosure agreements, organization officials said, they can't share exactly how much money they are providing.

The Side-Out Foundation, launched in 2004 by volleyball coach Rick Dunetz and his father, Bryant Dunetz, is designed to raise money to fight breast cancer through volleyball games across the nation. Bryant Dunetz said he heard about the professors' proposed trial through his wife's oncologist. She has been fighting breast cancer for 14 years and will be part of the clinical trial.

Petricoin said the trial will run for two years and involve 30 patients with metastatic breast cancer. Other partners in the trial include Fairfax Northern Virginia Hematology Oncology, which will arrange for the biopsies and administer treatment, and the Virginia G. Piper Cancer Center at Scottsdale Healthcare in Arizona, which will look at the genomic molecular profile of the sample while the professors study the protein side.

"To have this first study be a home run is unlikely, but the hope is it will get things" moving in the right direction, said Alex Spira, an oncologist with Fairfax Northern Virginia Hematology Oncology. "People have been talking about trying to personalize a patient's cancer care for years, but nobody has figured out a way until now."

People interested in the trial must be referred by their doctor, Petricoin said. Once the biopsy is in hand, it will take about a week to do the molecular testing and match the appropriate drug.

"We want to do this rapidly because patients with metastatic cancer" don't have much time, Petricoin said. "They are often ignored in medical trials, but we decided to go to those patients first, because if this really works, why not go to the patients who need it the most?"

Petricoin and Liotta have worked together since the late 1990s, when Petricoin was at the FDA and Liotta was at the National Institutes of Health. The two created the technology to study the protein pathways and were then recruited to co-direct the university's Center for Applied Proteomics and Molecular Medicine. If the trial proves successful, they said, medical professionals will have one more tool to combat breast cancer.

"We don't want to give patients false hope, but we are optimistic that the kind of information we are going to get has never been put together before," Liotta said. "This is a vision we had a long time ago and are finally getting to the clinical trial. If even one patient benefits, then that's what we care about."

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