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UofL offers vaccine trial for children with relapsed tumors at Kosair Children's Hospital

July 16, 2015

LOUISVILLE, Ky. - Zach feels "pretty good." Sam wants to be "done with shots!" And Tyler finds it helps to "just keep thinking that at least I'm getting out of school."

They are normal boys who had normal lives until cancer came into the picture. All have faced the disease for two years or more, with surgeries, chemotherapy and radiation treatments. All were diagnosed with various malignant solid tumors, went into remission and then relapsed.

Today, however, they and their parents are finding hope in a Phase I research study led by Kenneth G. Lucas, M.D., chief of the division of pediatric hematology/oncology and stem cell transplantation at the University of Louisville. Leading a team of his colleagues at Kosair Children's Hospital and in the UofL Department of Pediatrics, Lucas is making progress in developing a vaccine that one day could possibly prevent recurrence of some childhood cancers.

Lucas began the trial - the only one of its kind - while on the faculty of Penn State in 2011. Coming to Louisville in 2012, he now has three patients enrolled in the trial. Another 13 have previously completed the regimen. He uses the patient's own blood cells in developing the vaccine.

"The vaccine is designed to stimulate the patient's immune system to attack specific tumor proteins, and then fight the tumor," said Lucas, who also is the chief of pediatric hematology/oncology at Kosair Children's Hospital.

The vaccine is prepared and frozen in a cell therapy lab and then thawed for injection. Patients come to UofL's Kosair Charities Pediatric Clinical Research Unit for a week of chemotherapy that helps make the tumor cells express these cancer proteins. These proteins enable the tumors to be killed by immune cells that are stimulated by the vaccine.

The following two weeks are devoted to vaccination, followed by another two weeks of observation for side effects to the vaccine. The process is repeated four times, making the treatment take anywhere from four to five months. Thus far, the vaccine has been well tolerated by most patients, Lucas said.

Patients may be referred by their own physician or can self-refer, Lucas said. Anyone interested in the trial should contact KCPCRU@louisville.edu or 502-629-5820.

The trial is partially funded by the Children's Hospital Foundation and raiseRED, a dance marathon fundraising effort organized by UofL students to support pediatric cancer research.

Sam Rosebrock, age 5, Morganton, N.C.

Like any 5-year-old, Sam Rosebrock of Morganton, N.C., is anxious prior to his injection.

"I don't want a shot," he repeatedly said amid tears as mom Denielle Rosebrock comforted him. After the injection, he asked her, "Are we done with our shots?" Hearing that there would be no more injections, he was happy to repeat, "Done with shots! Done with shots!"

Sam had neuroblastoma, a type of cancer most commonly found in young children that develops from immature nerve cells found in several areas of the body. Sam's neuroblastoma was originally diagnosed in 2012 in the adrenal glands. Following chemotherapy, surgery, radiation, stem cell transplantation and antibody immunotherapy, he went into remission.

The cancer later came back in the groin area and left testicle. More chemo and immunotherapy followed, putting Sam into remission again. Sam's oncologist in Charlotte, N.C., learned about the trial in Louisville and Denielle said it was easy to make the decision to enroll him.

"With neuroblastoma, even when you have no evidence of disease, the likelihood of it coming back is extremely high," said Denielle, who with her husband, Mark, has another son, Isiah, age 10. "When you relapse, you have to do something."

Zach Hartwell, age 20, Lyndonville, Vt.

Doing "something" also is uppermost in the mind of Bill Hartwell, father of 20-year-old Zach who was diagnosed in 2011 with a medulloblastoma, the most common malignant brain tumor found in children and occurring in the cerebellum, which is the part of brain located at the base of the skull, just above the brainstem. Bill, wife Nancy and Zach have been on a four-state odyssey since diagnosis, from their home in Lyndonville, Vt., to Dartmouth, N.H., where the diagnosis was confirmed, to treatment in Boston and now to Louisville.

Along the way, Zach had surgeries, chemotherapy, radiation and more. He also experienced posterior fossa syndrome, a condition that affected his ability to move and speak.

Through a Facebook group, Parents of Kids with Medulloblastoma, Nancy learned about the experimental therapy.

"At 8 o'clock on a Saturday night, Nancy is checking Facebook and she saw information about Dr. Lucas and his trial, so she emailed him," Bill said. "At 10 o'clock, he returns the email - it was just that quick - and says he thinks Zach may be eligible."

Zach is the first patient in the trial with medulloblastoma. He receives a similar round of treatment as Sam: First week of chemotherapy, second and third weeks for vaccination, and fourth and fifth weeks for observation.

In speech halted by posterior fossa syndrome but still clear, Zach said, "I knew I was going to have to do something - chemo or radiation or both - and this just seemed like it was the better option."

"To us, this treatment seems like a very logical thing to do, a very logical approach. And much less invasive than the other treatments he has had," Bill said.

Tyler Foster, age 14, Beechmont, Ky.

The fact that the vaccine therapy is less invasive is a plus for Tyler Foster's dad, Michael Foster of Beechmont, Ky.

"This is a lot milder than any other treatment he has had," Michael said. "I believe this has been the easiest treatment he has faced."

Tyler is 14 and was originally diagnosed with osteogenic sarcoma in 2013 in his right knee, femur and lung. It also is known as osteosarcoma and is a type of bone cancer. It often starts in the ends of the bones where new bone tissue forms as a young person grows.

After chemotherapy and surgeries, Sam went into remission at Christmastime in 2013. In September 2014, the cancer came back, followed by more surgeries, including removing all of his femur and hip. He then underwent a rigorous chemotherapy regimen known as "ICE" - a three-drug combination of ifosamide, carboplatin and etoposide.

"It's hard enough to hear your child has cancer. That's a blow out of this world," said Michael, who with wife Susan has another child, Alexis, age 20. "And then to hear it a second time is even harder.

"ICE was hard, very, very hard. We almost lost Tyler a couple of times. He had feeding tubes. He was vomiting. He vomited up around 17 liters (of fluid) in one day.

"So that was a pretty rocky road. But he got better and had radiation after that."

Tyler speaks with the wisdom of a teenager who tests above his grade level but still is ... well, a teenager.

"When I heard I had cancer, my first thought was that I was going to get out of school for awhile," he said with a laugh.

The journey since, however, has the ginger-haired teen philosophical. "I just really have tried to not think too much about what was happening," he said, "and just look towards the future, that one day, I can get over this."

Hope for the future

That focus on the future is what keeps Bill Hartwell going, too. "We feel like this treatment is going to be the cure. People always talk about statistics, but we don't even think about that kind of stuff.

"We saw this trial, the treatment seemed to make good sense, and so we think ... this is going to cure Zach, and we're going to move forward from there."

Denielle Rosebrock has hope as well. "We don't get 'definites' (definitive answers) because it is a trial and it's very new," she said. "We also know that participating in the trial is one of our choices. We have to do something to prevent the cancer from coming back. We know there is a lot of promise in it."

"If this works, man, it would be terrific for other kids that face this," said Michael Foster. Adds Tyler: "It helps me to know that if this does work, it wouldn't put other kids through the same thing I've been through."
-end-


University of Louisville

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