By trusting in clinical trials, cancer patients spread the benefits of treatment innovations

In spring 2015, Trent Phillips of Jesup, Iowa, felt a nagging pain in the back of his left leg that didn’t seem to be getting better.

“I thought I had pulled a hamstring,” Trent says. “I had done it before, while playing sports. I told myself, ‘Well, hamstrings take a while to heal.’”

When the pain didn’t subside and a bulge started to form, he visited his doctor in Jesup, who referred him to an orthopedic surgeon in Cedar Falls. The surgeon ordered an MRI on the leg and, after seeing the results, called Trent back to his office.

“He sat me down and said, ‘I’m not an oncologist, but I’m pretty sure you have sarcoma in your leg,’” Trent says.

Sarcoma is a rare form of cancer that develops in bones or in soft tissue, such as muscles or tendons. It accounts for less than 1 percent of all cancer cases. Sarcoma is not only uncommon, it also has more than 150 sub-types. This means that physicians with the training and expertise to specialize in the disease are also quite rare—only about 50 currently practice in the United States.

Mohammed Milhem, MBBS
Trent’s surgeon referred him to Holden Comprehensive Cancer Center at the University of Iowa, where one of those hard-to-find sarcoma specialists is on staff: Mohammed Milhem, MBBS. His patients call him “Dr. Mo.”

Milhem met with Trent and asked if he would be willing to be the first participant in a clinical trial of a possible new treatment for sarcoma.

“It didn’t take long for Mo to prove to me that he was a smart guy and that this was a pretty tremendous facility,” Trent says. “He knows more about sarcoma than almost anybody in the world. And he’s got my best interests at heart.”

Milhem is passionate about the “forward thinking” that clinical trials enable—pushing the boundaries of what medicine can do to improve patients’ lives rather than relying on the standard of care.

“In my mind, the standard of care is substandard care, because you’re not incorporating ideas that might change the way we look at the disease,” Milhem says. “You are not pushing the scientist’s mind to truly innovate. And if you look at sarcomas in general, people who participate in clinical trials have better outcomes.”

In a clinical trial, patients agree to try a new type of therapy that may prove to be a better way to treat their disease. In this case, the trial drug is known as T-VEC, which had previously been shown to be particularly effective in treating melanoma. Based on those results, Milhem wanted to investigate T-VEC’s potential as a treatment for sarcoma.

Milhem has a deep appreciation for the “heroic effort” of patients who participate in clinical trials.

“Patients like Trent accept something unknown that may not only benefit them but will benefit the research community by answering a very important question and, at the same time, will benefit generations to come. I always tell patients, ‘You’re a hero. You’re fighting a battle on more than one level.’”

The standard of care for sarcoma is radiation followed by surgery. The Milhem-led clinical trial involves multiple injections of T-VEC that accompany the radiation treatments. When injected directly into the tumor, T-VEC causes cancer cells to self-destruct, and then it triggers an immune reaction, drawing white blood cells to the tumor. The radiation complements the T-VEC treatments by killing cancer cells and attracting even more white cells.

The goal is to train the white cells to recognize and remember the cancer cells and attack them—not just at the injection site, but anywhere those cells exist in the body, now and in the future. This is similar to how a vaccination protects the body against illnesses like measles. T-VEC has been shown to work that way with cancer cells in melanoma. This trial is an attempt to use that same process on sarcoma cancer cells.

Trent’s therapy consisted of 25 radiation treatments and 13 injections of T-VEC over five weeks, which killed 79 percent of the tumor.

There was some sickness after the first injection, “but all along, they’d say, ‘We’ll tailor the medicines.’ And they did,” Trent says. “Everything was pretty smooth from there. The stereotype of someone with cancer is that they’re wasting away. But I felt good the whole time.”

Benjamin Miller, MD, assistant professor of orthopedics and rehabilitation, performed surgery in October 2015, removing the tumor along with Trent’s hamstring.

By early 2015, two rounds of tests revealed no sign of cancer.

A professional graphic designer, Trent designed T-shirts that read, “Patient 001: Believing Matters,” and presented them to Milhem and the care team as his way of saying thanks.

“This was just about me putting my faith into what Mo had total belief in,” Trent says. “I saw his belief in it. I could hear it in his voice, see it in his eyes. And for me, that hope and trust and faith turned into reality.”

— Tony Craine
Spring/Summer 2016