Vaccine Tries to Keep Non-Hodgkin's Lymphoma in Remission

Editor's Note: This is the fifth story in a five-part series about clinical research at the University of Nebraska Medical Center. To learn more what clinical research is and the role it plays at UNMC, read the introduction to this series.

OMAHA - There's two places in the United States you can try an experimental vaccine made from your own tumor cells for one type of non-Hodgkins lymphoma: California's Stanford University, or the University of Nebraska Medical Center.

Choosing between the two was Jim Benson, an engineering professor from Kentucky. He's got stage four lymphoma, the worst stage; his cancer is in several lymph nodes in his neck and groin and has spread to his blood marrow. He wanted to be in a Phase II clinical trial for the vaccine, where all patients get the vaccine. That meant California or Nebraska. In Phase III trials, available at locations other than Stanford and UNMC, you could get the vaccine, or a placebo.

Nebraska, being closer to Kentucky, was the obvious choice because of the multiple trips he had to make for treatment and blood tests. He knew he could expect a short flight to Omaha, but didn't know the other benefit of seeing the nurses and doctors at the medical center.

"The level of empathy and concern, friendliness of the actual staff that's running the actual trial, is exceptional," Benson said recently from his room in the Lied Transplant Center, where he was resting after blood tests before catching a late-morning flight back to Kentucky.

Benson, 47, has follicular lymphoma, a common variety that makes up 15 percent to 20 percent of all non-Hodgkin's lymphoma cases. It's the one variety of non-Hodgkin's being targeted by vaccine trials, including one run by UNMC's Dr. Julie Vose. Non-Hodgkin's lymphoma is not a single disease, but a category of several closely related cancers of the lymphatic system. That's one of the most important parts of the immune system; it protects the body from disease and infection. A watery fluid called lymph contains white blood cells. The lymph flows through a network of vessels branching through the body, and filters through small organs called lymph nodes. When you're sick and get "swollen glands" on your throat under your jaw, those are some of your lymph nodes working to beat your illness.

How could a vaccine treat or cure cancer? Vaccines take a very small amount of a disease-causing bacteria or virus and put it in the body, where the immune system can practice defending the invader without being overwhelmed by a full-blown attack. The immune system "remembers" how to respond to that bacteria or virus. So when influenza, say, or diptheria attack the next time, the immune system can respond better and faster.

Turns out the immune system can be trained to remember and effectively attack follicular lymphoma, too. A company in California, Genitope, uses a patient's own cancer cells to make him or her a custom vaccine. It's a slow, painstaking process. First doctors take a biopsy, or sample, of a lymph-node tumor from a readily accessible spot -- say, under the arm. Using genetic engineering and cell cloning, the sample cells are modified slightly and joined with KLH, a substance found in mussels (a sea mollusk) to which nearly everyone's immune system responds. The patented technique takes six months to complete.

It's still ready in plenty of time. Clinical-trial patients go through a standard six-month course of chemotherapy treatment to put their cancer in remission, then rest for another six months while their immune systems recover from the poisonous onslaught of the chemotherapy drugs. Only then are they given the vaccine injection -- once a month for four months, then once more three months after the fourth shot. Patients receive two subcutaneous (just beneath the skin) injections in the same spot each time. One is the vaccine/KLH combination, another a protein called Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) that helps the body identify foreign substances.

Follicular lymphoma responds well to chemotherapy, going into remission in many instances. Unfortunately, it seems to always come back. The vaccine therapy being tested at UNMC aims to stop that, but it takes quite a bit of patience to work with this treatment.

"Since the patients take 10 years to relapse, you have to wait a long time to find out beneficial results," Vose said.

This Phase II trial of the follicular lymphoma vaccine is just one of three trials Vose is now running. The doctor's busyness has meant a wealth of opportunity for her assistant, nurse Susan Blumel. She finds potential trial participants, gets and keeps them enrolled, juggles insurance requirements and travel schedules, and writes frequent reports to the medical center's Institutional Review Board and the Food and Drug Administration. As if that were not enough, she also gives the vaccine shots.

Blumel, a certified clinical research coordinator, has had the opportunity to further her career by writing abstracts and giving talks about her and Dr. Vose's work. All the while, she gets to be right there at the patient-care level seeing real people get potentially life-saving treatment. Follicular lymphoma may be a very slow-growing cancer, but it still means death 7 to 10 years after diagnosis.

"It's very fulfilling working with patients on this level, because we're looking for better ways to treat lymphoma," Blumel said.

Blumel credits Vose with a knack for finding clinical trials that have a lot of potential. This trial, for example, adds on to the traditional regimen for treating lymphoma, yet holds very little extra danger for the patient.

"We're trying to prolong remission with relatively low risk," Blumel said.

Blumel has respect for the trial participants, who fly in from all over the country to see whether they can help themselves and people like them.

"These people are in remission," she said. "They could choose not to do anything. So the people that participate in the trial, I think, are future-lookers."

Benson, the Kentucky professor, looked to the future when he volunteered -- the future of lymphoma patients he'd befriended through support networks.

"That's one of the reasons we made the decision," Benson said. "Because even though they tout this disease as a 60-year-old disease (affecting people that old and older) … these people range from 31 years old to 51 or 53.

"If this can help anybody with that much life left, that's good thing."

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This story originally appeared in Nebraska StatePaper on July 27, 2001.