Clinical Research News

Trial of New Vaccine for Stage IV Kidney Cancer

When the vaccine is injected into patients, the virus enters specialized cells known as "antigen presenting cells." Once in these cells, the vaccine produces 5T4, an antigen naturally made by the kidney cancer cells. This induces an immune response and activates antibodies (shown) and T cells directed against the 5T4. This results in destruction of the kidney tumor cells by the immune system. ILLUSTRATION CREDIT: Nancy Heim

Since the first vaccine for smallpox was documented in 1796, scientists have developed effective vaccines to prevent numerous deadly diseases, including cholera, anthrax, typhoid fever, and the plague in the 1800's, and polio, measles, and mumps in the 1900's. With these and other scourges behind them, researchers have since turned their focus to the most challenging killers today, including cancer. Once considered a pipe dream, the possibility of preventing or curing cancer with vaccines is now within our reach — and an important new trial at NewYork-Presbyterian Hospital/Columbia now promises to advance the field even closer to that goal.

Researchers at the Tumor Immunotherapy Program of Columbia University Medical Center and New York-Presbyterian Hospital have begun testing the safety and efficacy of a new tumor vaccine, TroVax, in conjunction with Interleukin-2 (IL-2). IL-2, which stimulates the immune system to recognize and destroy cancer cells, is already approved for the treatment of advanced kidney cancer. The TroVax trial gained institutional approval in October 2004 and began shortly thereafter.

Cancers are able to spread through the body in part because the immune system cannot distinguish cancer cells from normal tissue, and does not destroy cancer cells as it would attack a foreign invader such as a bacteria or virus. Researchers are hoping that they can use vaccines to alert the body to the presence of cancer cells. Research indicates that vaccines can stimulate the immune system to recognize and attack both the vaccine agent and, subsequently, the cancer cells.

The Tumor Immunotherapy Program is currently investigating vaccines for both prevention and treatment of a range of cancers, including kidney, colorectal, pancreas, prostate, and skin (early and metastatic melanoma). Vaccines can be developed from viruses, small proteins, or whole cells; they are still experimental, and standards for optimum delivery remain to be established. The program, under the direction of Howard L. Kaufman, MD, is a multidisciplinary team that works to develop new vaccines, test them, and make them available to patients.

The trial of TroVax and IL-2 will determine whether TroVax effectively stimulates an immune response in patients with advanced kidney cancer who are receiving IL-2. It will test for side effects and will assess how well TroVax improves tumor response rates compared to IL-2 therapy alone.

"The innovative aspect of this trial is that we are utilizing two complementary forms of immunotherapy together in an effort to increase the clinical response rate. This is based on extensive animal data supporting this combination and early clinical trials in patients with advanced forms of melanoma. This trial will be one of the first ever conducted in kidney cancer using a defined antigen vaccine with high dose IL-2," says Dr. Kaufman.

Candidates for the trial include patients aged 18 or older who have metastatic renal clear cell adenocarcinoma, and who are eligible for high dose IL-2 therapy.

For more information about tumor immunotherapy, please visit www.tumorvaccines.com. To contact the Tumor Vaccine Program about the TroVax-IL-2 trial, physicians may contact Gail DeRaffele, RN at 212.342.0232.