Recently the first patient was vaccinated at NYU Medical Center with a specific cancer vaccine designed to prevent tumor recurrences in patients who have already had a kind of cancer called follicular lymphoma.

Lymphoma is a cancer that begins in the lymph nodes. Malignant white blood cells multiply and grow into tumors, enlarging the lymph nodes and other sites in the body. There are many kinds of lymphoma, but one of the most common forms is follicular lymphoma, a low-grade or slow-growing form of the disease.

"Patients with follicular lymphoma are generally diagnosed in their sixties; however, in recent years we have seen an increased incidence in younger individuals in their thirties or forties," explains Giorgio Inghirami, M.D., Associate Professor of Pathology, NYU School of Medicine, who is one the physicians leading the clinical trial.

Even with treatment such as chemotherapy, follicular lymphoma re-develops in virtually all patients. The Leukemia and Lymphoma Society estimates that about 61,000 Americans will be diagnosed with lymphoma this year; about 25,000 of these people will have follicular lymphoma. Consequently, this type of tumor represents one of the most common forms of lymphoma in industrialized countries. Non-Hodgkin's lymphoma, which includes follicular lymphoma, is the fifth-most-common cancer in the United States.

The lymphoma vaccine is designed to eliminate any cancer cells that are left over after chemotherapy, and therefore prevent the disease from recurring. The vaccine was developed over the past ten years at the National Cancer Institute (NCI), and it has already undergone Phase I and Phase II trials. These trials are designed to show only that it is safe for use in humans and to evaluate its clinical efficacy in a small number of patients.

The results of these early trial stages were striking--the vaccine prevented the recurrence of the disease in about 85 percent of cases, and many are still in remission. However, further testing is needed in a much larger number of patients. The current Phase III trial is expected to recruit about 500 patients nationwide.

The vaccine is unique in that each dose is tailor-made from each individual patient. It is based on proteins specifically found on the patient's tumor cells, which serve as a biochemical alarm system for the person's own immune system. These proteins are administered together with an immune booster called GM-CSF and a so-called carrier protein. In essence, the vaccine stimulates specialized immune cells in the body to target and destroy malignant white blood cells. Two-thirds of the participants in the trial will receive the tailor-made vaccine, and the remaining patients will receive a nonspecific vaccine that only contains the carrier protein and the GM-CSF.

According to the National Cancer Institute, the Phase III study is the first and only vaccine trial for non-Hodgkin's lymphoma that uses patients' own tumor cells.

NYU School of Medicine is actively recruiting patients for this vaccine trial. Patients must be newly diagnosed with low-grade follicular lymphoma and must not have had any previous treatment. Trial patients will be given chemotherapy, and once their cancer is in remission, they will be eligible for the vaccine. Patients who are members of minority groups are particularly needed as participants in the trial.

The success of this trial could have implications that go beyond treating this particular cancer. "If the vaccine is proven to function," says Dr. Inghirami, "it's possible that other kinds of lymphoma could be tagged this way."

The trial is being sponsored by the National Cancer Institute in collaboration with Biovest International, a company based in Minneapolis, which is producing the vaccine. In addition to NYU Medical Center, the trial is being held at seven other hospitals nationwide.

Potential trial participants should call 212-263-5967 or 212-263-5466 or 212-263-2936 for more information.