First US kidney cancer vaccine trial underway at Columbia

01/27/05

Study of a completely new way of trying to treat cancer in the future by the use of vaccination injections

The first U.S. kidney cancer vaccine trial is now underway at Columbia University Medical Center and NewYork-Presbyterian Hospital/Columbia. While the potential for vaccines to treat solid tumors has been recognized for more than a decade, this trial is pioneering the use of tumor immunotherapy – boosting the body's natural immune system – as a way to fight cancer.

"Vaccines are an exciting prospect in cancer treatment and this trial is an example of our program's dedication to bringing the latest advances in tumor vaccines and immunotherapy to patients with cancer," said Howard L. Kaufman, M.D., associate professor of surgery and pathology at Columbia University Medical Center and director, Tumor Immunotherapy Program at NewYork-Presbyterian/Columbia. "We expect that combining IL-2 with Trovax will double the treatment response rate for our kidney cancer patients, offering new hope for these patients."

Vaccines, usually associated with the prevention of infectious diseases, e.g., measles, help the body's immune system recognize and kill foreign invading organisms. Recent research has provided evidence that vaccines may also be useful for preventing or treating cancer. Tumor vaccines contain a specific protein of the tumor cell that stimulates an immune response.

In the study, patients with stage IV renal cell carcinoma are given regular doses of an investigational kidney cancer vaccine, called Trovax, in conjunction with Interleukin-2 (IL-2). High-dose IL-2 is currently the only approved treatment for kidney cancer, and Columbia University Medical Center and New York-Presbyterian Hospital/Columbia are the only site in New York to offer IL-2. Kidney cancer is one of the few cancers for which chemotherapies are not effective treatments.

A small protein (cytokine) naturally produced by the cells of the immune system, IL-2 stimulates T-cells, which are activated in an immune response system and create tumor killing cells. The response rate (i.e., rate of tumor shrinkage) of IL-2 given alone is typically 17-25 percent. While IL-2 stimulates all T-cells, the Trovax Vaccine helps IL-2 selectively target only cancer cells, reducing side effects by not targeting and unnecessarily killing normal cells. Trovax has shown promise in similar trials conducted in Europe in colon cancer.

About Trovax

Trovax belongs to a class of medicines called a vaccine. Trovax consists of a virus that has been changed so that it is no longer infectious and carries a gene for a protein called 5T4. This protein is carried by many kidney cancer calls. When the virus is injected, it makes the protein, and the body's immune system is then able to recognize this protein and kill the cells that have it (i.e. the cancer cells).

About the Trial

The Trovax vaccine with IL-2 trial is being conducted by a team of physicians, scientists, nurses, pharmacists, and social workers with expertise in the use of immunotherapy in patients with cancer.

The trial aims to enroll 25 patients in total. To date, two patients have enrolled. Patients need to meet certain medical requirements to join the clinical trial. An interested patient or medical oncologist may contact us to learn about eligibility requirements. Participation is voluntary and patients may withdraw at any time.

For more information regarding participation in one of our trials, please contact Gail DeRaffele, RN, Clinical Coordinator at 212-342-0232 or gd2023@columbia.edu.

The Tumor Immunotherapy Program at NewYork-Presbyterian/Columbia, unique in the Metropolitan New York area, includes doctors and nurses with specialized training in biologic therapy and vaccines who are actively conducting clinical studies of tumor vaccines. The program also includes scientists working in research laboratories within Columbia University to translate clinical learnings into new vaccines and therapies.

Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, medical education, and health care. The medical center trains future leaders in health care and includes the dedicated work of many physicians, scientists, nurses, dentists, and other health professionals at the College of Physicians & Surgeons, the School of Dental & Oral Surgery, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. With a strong history of some of the most important advances and discoveries in health care, its researchers are leading the development of novel therapies and advances to address a wide range of health conditions.

New York-Presbyterian Hospital is the largest not-for-profit, non-sectarian hospital in the country. It provides state-of-the art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: New York-Presbyterian hospital/Columbia University Medical Center, New York-Presbyterian Hospital/Weill Cornell Medical Center, Children's Hospital of New York-Presbyterian, the Allen Pavilion, and the Westchester Division. It consistently ranks as one of the top hospitals in the country in U.S. News & World Report's guide to "America's Best Hospitals." The New York-Presbyterian Healthcare System – an affiliation of acute-care and community hospitals, long-term care facilities, ambulatory sites, and specialty institutes –serves one in four patients in the New York metropolitan area.

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