Pancreatic Cancer Vaccine Trial Opens at NYP/Columbia’s Pancreas Center

by Columbia Surgery on May 26, 2011

M. Wasif Saif, MD, MBBS

Unlike some other forms of cancer, pancreatic cancer is often detected only in advanced stages, making it one of the most deadly forms of cancer overall. Surgical removal of tumors is possible in only 10% to 20% of patients, chemotherapy is not nearly as beneficial as patients and physicians would hope, and the risk of recurrence after treatment is high. Given these conditions, researchers are working hard to develop alternative therapies that extend patients’ lives past the average survival time, 20 months after diagnosis.
One of the most promising areas of research entails development of vaccines to harness the immune system to fight the cancer from within. An important study at NewYork-Presbyterian/Columbia’s Pancreas Center is now moving this concept one step closer to reality. The trial is studying whether a new vaccine, developed specifically to target pancreatic cancer cells, will help to prevent recurrences among patients who have had pancreatic tumors surgically removed.

The trial includes two arms: 350 patients will receive chemotherapy alone or with radiation therapy, and 350 will receive chemotherapy alone or with radiation, plus the new pancreatic cancer vaccine. Those receiving the vaccine will receive a series of injections, administered one month apart, beginning 8 to 10 weeks after surgery. Patients will be monitored every three months for the first 36 months, every 6 months for 2 years, and then annually to determine whether the vaccine helps to reduce the rate of recurrence.

The vaccine in this phase III trial was developed on the basis of a hypothesis called hyperacute immunotherapy. According to M. Wasif Saif, MD, MBBS, immunotherapy works by causing “hyperacute rejection:” in the way that other vaccines cause the body to develop an immune response against measles, polio or another disease, the pancreatic cancer vaccine triggers an immune reaction that leads to immunity against specific pancreatic cancer cells. In this case, the pancreatic cancer vaccine is produced using alpha-GT epitopes from mouse cells, which are not found on human cells. These epitopes cause a reaction that leads human cells to attack pancreatic cancer cells from within (called cell mediated immunity).

Data from a multicenter phase II study (preceding the current phase) showed encouraging results for this therapy. At 12 and 24 months after surgery, survival rates were 91% and 54% respectively, which is a significant improvement upon the median survival rate of 16 months. Patients are still being followed up to determine long-term survival benefits.

The phase III trial opened at NewYork-Presbyterian/Columbia in late April 2011. Dr. Saif strongly encourages eligible patients to consider enrolling in this trial. As he explains, “This is an important study for every patient and family member with pancreatic cancer. It is very important to come to centers that offer this study, and to understand that we now have more therapies to offer to patients with pancreatic cancer.”
To read about hyperacute immunotherapy for pancreatic cancer, see Dr. Saif’s March, 2011 article in the Journal of the Pancreas, Adjuvant therapy of pancreatic cancer: beyond gemcitabine. Highlights from the “2011 ASCO Gastrointestinal Cancers Symposium”. San Francisco, CA, USA. January 20-22, 2011.
For information about pancreatic cancer, treatments at the Pancreas Center, and other clinical studies, please visit The Pancreas Center.