Dec 9 4:00 PM

Using altered HIV cells, leukemia treatment shows long-term remissions

by David Martin @Stories_Live

It wasn't long ago that Bob Levis was in pain whenever he moved. But a clinical trial to treat his cancer helped save his life.

America Tonight

Less than a year ago, Bob Levis was dying. Chronic lymphocytic leukemia raged throughout his 61-year-old body, swelling his lymph nodes and infiltrating his organs. Most dangerous of all, cancerous cells packed his bone marrow, crippling his immune system and preventing the production of red blood cells and their life-sustaining oxygen.

Levis was pale, weak and living from blood transfusion to blood transfusion. Once an avid cyclist and golfer, he now barely had the energy to wheel his garbage to the end of the driveway. Fearful of a potentially lethal infection, he wore a mask anytime he left house. The businessman who had lived and worked throughout Asia stopped traveling altogether, and he avoided malls and children because they might expose him to germs that could kill him.

As 2012 came to a close, Levis hunkered down with his wife, Sue, at their hillside home outside Allentown, Pa., and devoted what little energy he had left to preparing his will. He summed up 2012 as a “pretty dismal year.”

But in January, Levis received a call that would save his life — an invitation to join a clinical trial at the University of Pennsylvania that offered a revolutionary new therapy using HIV to fight leukemia. The trial was reserved for the hopeless cases, people for whom no other treatment was available. Levis became patient 15.

Patient 15

Months earlier, he had contacted the head of the trial at Penn, Dr. Carl H. June, after reading a story in The New York Times about the first few patients treated. June remembers Levis’ email among a tidal wave of desperate pleas that followed the article.

“I had over 5,000 emails from people who wanted to be treated, and many of them had a leukemia or other kinds of cancers, and they’re from all over the world,” June said. “In that flood of emails, one was from Bob Levis. I had no idea who he was.”

Levis was one of the few invited to take part in the fledgling trial.

“To even be eligible for the protocol,” said June, “you have to have no hope left, meaning there’s no FDA-approved therapy that will work. And that was especially true in his case. There are markers in the tumor telling how fast it will progress, and he had one of the worst.”

Levis’ life expectancy at that point, June added, was in the “low number of weeks to months.”

Before coming to Penn, June had spent 21 years as a physician-scientist in the Navy, where he studied HIV. In working to combat the AIDS epidemic, he and others learned a great deal about HIV, so much that he thought the killer virus could be manipulated and used as a lifesaving tool.

“That virus is understood at a molecular level, at a level unprecedented of many other viruses, including the common cold virus,” June said.

"To even be eligible for the protocol you have to have no hope left, meaning there’s no FDA-approved therapy that will work. And that was especially true in (Levis') case. There are markers in the tumor telling how fast it will progress, and he had one of the worst."

Dr. Carl H. June

University of Pennsylvania

To harness HIV, June’s team removes the genes that cause the disease and those that make it infectious, leaving genetic coding that helps a patient’s own T-cells find and kill leukemia cells in the body. T-cells are white blood cells, part of the body’s natural defenses. Normally, T-cells don’t see cancer cells.

In January, Levis traveled to the University of Pennsylvania’s hospital to have T-cells extracted from his blood. The researchers grew them in the lab, reprogrammed them with the genetically modified HIV and gave Levis a 15-minute infusion containing these cancer-killing T-cells.

'It's a cellular war'

As part of the leukemia treatment, the clear cell, lower left, engages with the green cells, which are considered tumor cells. Soon after this engagement, the green tumor cell starts to die.

Michael Milone, PhD

Within days, these special T-cells had multiplied in Levis’ body and began going after the leukemia cells.

“It’s a cellular war,” June said. “The T-cells become what have been called serial killer cells. They literally go from one tumor cell to the next and kill them.”

All this cellular havoc creates horrible flu-like symptoms as dying cancer cells produce inflammation in the body. For a week, Levis’ temperature topped 104 degrees and his heart rate hit 100 beats a minute.

“It stayed there, 24/7, for seven days. Boom, boom, boom,” Levis recalled. As miserable as he felt, he was happy. “I felt that this is it. It’s working. I’m anxious to see some bloodwork.”

He had dropped 20 pounds on his already lean frame. He was weak but otherwise felt fine. When the bloodwork came back, his cancer was completely gone.

“You just can’t believe it,” Levis said. “It’s just amazing that something can happen that quickly. A miracle, just a miracle. You got your life back.”

He is not alone. On Saturday, Penn researchers announced that 31 of the 59 adults and children were cancer-free after receiving this ultrapersonalized treatment. One man remains cancer-free after three and a half years; six of these end-stage patients have had a recurrence of their cancers.

The modified T-cells have also flourished in the patients in remission, multiplying and serving as a vaccine of sorts against a recurrence of their leukemia, June said.

Back to school

Emily Whitehead was given only days to live. After becoming the first pediatric patient to receive the T-cell treatment, she is now cancer-free.

Children's Hospital of Philadelphia

One of those who remain cancer-free is Emily Whitehead. She missed more than half of her kindergarten year and all but a few days of first grade, spending much of that time in the hospital as treatments failed and her health deteriorated.

“She had only days to weeks left, because everything they tried just had not worked,” June said. “Leukemia that’s out of control is a very rapidly lethal disease.”

Emily became the first pediatric patient to receive the T-cell treatment, and she remains cancer-free. She’s now in third grade in Phillipsburg, Pa., getting straight A’s and trying to decide whether to become a teacher, veterinarian or artist, said her father, Tom.

He said he thinks every day about how close his daughter came to death.

“We would have walked to the North Pole to save her life,” he said. “If you look at her today and you didn’t know what she went through, she looks like a normal third-grader.”

Outcomes like Emily's have gotten people's attention. Though the Penn results are only preliminary, they are promising enough to have attracted a $20 million investment from the Swiss pharmaceutical giant Novartis to build a first-of-its-kind Center for Advanced Cellular Therapies on campus.

The trials are expected to expand, not only to include more leukemia patients but also to test the approach against such other cancers as mesothelioma, pancreatic cancer and lung cancer.

“The whole field is now saying, ‘If you can do this in patients with late-stage cancer, why not do it and actually prevent cancer?’” June said.

'Planning forward'

Levis is back to playing golf and riding his bike. He has started doing consulting work, and he’s taking on what he can to help support leukemia research. In January, he and his family are planning a trip to Maui, Hawaii, to celebrate his survival.

When you watch Levis ride his bike on the rolling hills near his home, it’s hard to imagine that his health was failing so recently.

“A year ago, I thought I was going to die. I was preparing to die,” he said. “Now I’m planning forward again.”