January 28, 2003

Lymphoma Clinical Trial
Tests 'Customized' Vaccine

Researchers with the Rebecca and John Moores UCSD Cancer Center are conducting a clinical trial to test the effectiveness of a patient-specific, or customized, vaccine against non-Hodgkin's lymphoma (NHL). Rather than providing protection against the disease, as with a flu vaccination, cancer vaccines are designed as a therapy for those who have the disease by harnessing the patient's own immune system to eradicate cancer cells.

The vaccine is made from a protein found on cells taken from the patient's lymph nodes and mixed with a substance that boosts the immune system's ability to recognize a molecule on the surface of each lymphoma cell. The molecule is unique to the lymphoma cells of a particular patient and can therefore function as a specific target against which an immune response can develop. Favrille, Inc. manufactures the vaccine under the trade name FavId.

The therapeutic vaccine is injected following an autologous stem cell transplant. In this type of transplant, the patient's stem cells are removed before high-dose chemotherapy is administered, and then given back afterward to replenish the body's supply of blood cells.

To be eligible for the study, patients must be diagnosed with low-grade or mantle cell non-Hodgkin's lymphoma (NHL). Also eligible are patients whose low-grade NHL has transformed to high-grade NHL.

The Phase II multi-center study is designed to test whether or not post-transplant patients would develop an immune response to the vaccine, and, if so, would this keep patients in remission longer than would be expected following a transplant alone.

Three months after transplantation, participants receive four monthly injections of vaccine followed two months later by a fifth injection.

So far four participants have completed the protocol at UCSD and three have mounted an immune response. The first patient on the study received his final vaccination in May 2002 and remains in remission with no further treatment (see sidebar below).

Principle Investigator, Peter Holman, M.D., with patient

"While it is early in the process, the strength of the immune response results gives us hope that we may see prolonged remissions," said the Cancer Center's Peter Holman, M.D., UCSD assistant clinical professor of medicine and principal investigator of the study.

Holman is also conducting a non-transplant clinical trial in which patients receive the monoclonal antibody Rituxan before receiving the vaccine regimen.

"If patients continue to have an immune response, they are eligible to receive ongoing maintenance injections at no charge," said Holman.

Non-Hodgkin's lymphoma is one of three cancers that have been increasing in incidence over the past 20 years; the others are lung cancer in women, and melanoma. There has been an 81 percent increase in NHL overall since 1973. The reasons for this increase are not well understood, although environmental agents have been implicated, along with hepatitis C and HIV. There were 54,000 new cases of NHL in the U.S. in 2002, representing 4 percent of all cancers.

For further information about these and other cancer clinical trials available at UCSD, please call the Cancer Center's Clinical Trials Office, 858-657-7020, or visit the Center's website: www.cancer.ucsd.edu

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Patient Sidebar

For the last eight years, since being diagnosed with Stage IV non-Hodgkin's lymphoma, Galen Hermesch has been living one day at a time. Before enrolling in a therapeutic vaccine study at UCSD, he had gone through numerous treatment approaches and had relapsed three times.

The 56 year old from Rancho Mirage is hoping that the third time will prove to have been the charm.

"Until now, my longest time in remission was eight months," Hermesch said. "It's been 16 months since my autologous stem cell transplant, and eight months since my last vaccination and there are no indications of any recurrence."

While Hermesch knows that the vaccine is experimental and that he may have a recurrence of his disease, he is for the first time in nearly a decade thinking about the future.

"Without this treatment, I know the disease would have been a continuing issue until it took my life," he said. "While there's no way to say for certain that it's the ultimate answer, it offers the most positive thing that I have experienced in the last eight years. All of a sudden, it seems, I have a future again."

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News Media Contact:
Nancy Stringer