Clinical Trial for Pancreatic Cancer Patients at GU Hospital

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Georgetown University Hospital is taking part in a clinical trial to assess the safety and effectiveness of TNFerade (TM) Biologic, with fluorouracil (5-FU) and radiation therapy, for first-line treatment of newly diagnosed, unresectable, locally advanced pancreatic cancer—cancer that has not spread from the pancreas to nearby tissue or lymph nodes. TNFerade (TM) has been granted “Fast Track” product designation by the U.S. Food and Drug Administration.

“This study, and related work here at GUH, draws upon the unmatched expertise of colleagues in radiology, gastroenterology, surgery, medical oncology, and radiation medicine to offer patients with this difficult disease an opportunity to receive better treatment,” says John Marshall, MD, chief of the Division of Hematology-Oncology and principal investigator for the trial at Georgetown.

“The pancreas is a challenging location,” explains Dr. Marshall. “It performs many digestive and hormonal functions, it has many blood vessels, and many other major structures run right next to it. So it is common to find tumors, even with no evidence of metastasis, and not be able to operate on the patient. Surgery remains the only curative treatment, but unfortunately even that does not help many people. Even if the tumor is surgically removable, a very high proportion of patients – 80 percent or so – will have microscopic spread of the disease that will ultimately prove fatal.”

The TNFerade (TM) trial, rather than striving to prepare participants for surgery, is designed to offer longer patient survival, with the ultimate aim of controlling the disease. In the first phase of this trial, which is being conducted at various sites throughout the country and will last about five weeks, all participants will receive standard of care treatment with 5-FU (delivered by pump) and radiation therapy. Some participants will also receive TNFerade (TM), administered by direct intratumoral injection –– a novel mode of delivery –– using a percutaneous approach (guided by CT scan or MRI) or endoscopic ultrasound. The appropriate dose was determined through an earlier study, in which Georgetown also took part. In the second phase of the current trial, participants will go into routine care, and receive gemcitabine (Gemzar) by intravenous infusion.

Pancreatic cancer has one of the highest fatality rates of all cancers and is the fourth-highest cancer killer in the United States among both men and women. Although it accounts for only two and a half percent of new cases, pancreatic cancer is responsible for six percent of cancer deaths each year. One reason treatment is so challenging is that most patients will have advanced disease on presentation. Only 15 to 20 percent of all patients with newly diagnosed pancreatic cancer will meet the criteria for resection. Currently there are limited treatment options available for those with unresectable, locally advanced pancreatic cancer, making this trial especially significant.

TNFerade (TM) uses patented adenovector technology (GenVec, Inc.) to deliver the tumor necrosis factor-alpha gene directly into the tumor; there it interacts with standard radiation therapy to produce the therapeutic protein, TNF-alpha. A radiation-inducible molecular switch is incorporated into TNFerade (TM), allowing maximum gene expression and therapeutic protein secretion only when the target tissue receives standard radiation therapy. With this approach, it is thought that TNFerade (TM) has the potential to make radiation therapy work better, with fewer side effects.

Georgetown offers patients with all forms of pancreatic disease, including cancer, the full range of current therapies, supplemented by the potential to participate in promising research, of which this trial is an example. 

By Eve Katz, PhD, excerpted from the Winter 2009 issue of Georgetown Physician Update