(ArmyTimes.com) - Kellie Trombitas fought through surgery and two rounds of chemotherapy for 10 long, difficult months before she was declared cancer-free Dec. 21.
But one thought always lingers in her mind.
"I hope it never comes back," said Trombitas, the wife of Maj. Gen. Simeon Trombitas, commanding general of Army South at Fort Sam Houston, Texas. "That's always on our minds. Thinking about doing all of this again is sometimes too much."
Trombitas volunteered to join a worldwide clinical trial - being conducted by her doctor among others - for a breast cancer vaccine that could erase her fears for good. On Jan. 19, she became the first patient in the study, which is still looking for other volunteers.
Developed by Col. (Dr.) George Peoples, chief of surgical oncology at the San Antonio Military Medical Center, NeuVax is a vaccine that targets breast cancer patients who have been treated and are in remission. Its goal is to reduce or eliminate the risk of the cancer recurring.
Peoples, who also is the director of and principal investigator for the hospital's Cancer Vaccine Development Program, has worked on this vaccine, which carries the generic name E75, since the early 1990s.
The trial is the final step before Food and Drug Administration approval. It is being conducted by Galena Biopharma, a Portland, Ore.-based biopharmaceutical company, because of its size, scope and cost.
At least 700 participants will be needed for the three-year trial, to be conducted at 70 to 80 locations across the country and around the world, Peoples said. He already has conducted two trials on the drug, with promising results, he said.
Typically, if cancer were to recur, it would happen within two to five years, Peoples said.
CUTTING RECURRENCES IN HALF
During the most recent trial, which had 200 participants, about 20 percent of patients in the control group had a recurrence of cancer, which is consistent with historical norms and data, Peoples said. Among those who received the vaccine, the recurrence rate was cut in half, he said.
Peoples said he hopes this latest trial will produce even better results than his previous trial.
"We learned how to more properly dose the vaccine and the need for long-term boosting," he said. "Among the women who were optimally dosed and boosted [in the last trial], we only had a single woman recur."
Participants in the Galena-run trial will receive a shot once a month for the first six months and then a booster shot every six months for the rest of the three-year trial, Peoples said. It will take the company about 18 months to enroll all 700 patients.
"They're looking for the number of recurrences," Peoples said. "The highest risk of recurrence is in the first two to three years. The end point [Galena] and the FDA decided on was the recurrence rate at the end of three years. Hopefully, we'll see a much lower recurrence rate among the vaccine patients compared to the control group."
Peoples also is looking to conduct a trial that combines Herceptin, a drug approved for use in fighting breast cancer, with NeuVax.
If NeuVax succeeds, Peoples sees potential for it to be used in treating other types of cancer; the protein it targets, HER2/neu, is present in many types of cancer, including lung, prostate, colon and ovarian cancers, he said.
The field of cancer vaccines has been "one of those areas of promise for many, many years with a lot of failures and disappointments along the way," Peoples said. The first cancer vaccine was approved by the FDA in 2010 for prostate cancer, and another drug was approved in 2011 for melanoma, he said.
"There's been a huge amount of interest building in this area because we have now our first two FDA-approved products, and we'd be the next in line, if you will, to have a product that could be approved by the FDA as a vaccine," he said. It's gratifying, Peoples said, to see his years of research make it this far and show such promise.
POSSIBLE HELP FOR OTHER CANCERS
"If we prove the concept in this group of women, then that would spur on the research to find even better vaccines that are more affable to the wider range of breast cancer patients," he said. "And if we show this works in breast cancer, we could, in fact, test in other cancers. It holds a lot of promise. If this trial works out, not only would it work for breast cancer, but it could open the doorway for these other cancers, as well."
Trombitas, who doesn't know if she received the vaccine or is in the control group, said she is excited about the possibilities stemming from this vaccine.
"I think it is wonderful how things are changing, and there are all kinds of treatment for cancer," she said. "That's how you move forward. You want to do everything you can to prevent it from coming back. I'm very excited about it, regardless of the outcome. I can't wait to see what happens with this in the future."
Michelle Tan, Army Times