Surgery for Pancreatic Tumors and Collection of Tumor Tissue for Study
Surgery for Pancreatic Tumors and Collection of Tumor Tissue for Study
This study will examine pancreatic tumor tissue and immune cells from patients with a
 pancreatic tumor to look for markers on these cells that may be useful in developing new
 treatments for the disease.

 Patients 16 years of age and older with any evidence of a primary pancreatic tumor that can
 be surgically removed may be eligible for this study. Types of pancreatic tumors included in
 this trial are pancreatic cancer, adenosquamous carcinoma, anaplastic carcinoma, IPMN
 (intraductal pancreatic mucinous neoplasm), acinar cell carcinoma, pancreaticoblastoma,
 mucinous cystic neoplasms, serous cystic neoplasms, solid-pseudopapillary cystic neoplasms,
 squamous cell carcinoma, Vater (ampullary tumors) duodenal adenoma or cancer and common bile
 duct tumors (cholangiocarcinoma.) The specific type of tumor does not have to be determined
 before the operation. Candidates are screened with a medical history and physical
 examination, computed tomography (CT) or magnetic resonance imaging (MRI) of the chest,
 abdomen, and pelvis, blood and urine tests, and an electrocardiogram. Patients older than 50
 years of age and patients with a history of cardiovascular disease may also have a thallium
 cardiac stress test.

 Participants undergo standard treatment for their pancreatic tumor, including surgery to
 remove the tumor. Before, during, and after the operation, several blood samples are drawn as
 part of routine patient care and for research tests. During the surgery, a small piece of
 tumor tissue is taken for examination under the microscope and to grow cells in the
 laboratory for tumor and immune cell studies. Some patients may undergo leukapheresis to
 collect large numbers of white blood cells for study. For this procedure, blood is collected
 through a needle in an arm vein and flows through a catheter (plastic tube) into a machine
 that separates it into its components by centrifugation (spinning). The white cells are
 extracted and the rest of the blood (plasma, red cells, and platelets) is returned through
 another needle in the other arm.

 Patients who require additional treatment, such as chemotherapy or radiation, may be treated
 at NIH on another protocol or referred for appropriate treatment elsewhere.
Background:

 -  Effective standard treatment options are currently not available for exocrine pancreas
 carcinomas. Adenocarcinoma of the pancreas, the most frequent exocrine tumor, is the
 fourth leading cause of cancer related deaths in men or women in this country.

 -  Immunotherapy for melanoma as studied in the Surgery Branch has resulted in striking
 tumor regression in some patients.

 -  Procurement of lymphocytes and tumor from patients with pancreas cancer will facilitate
 the identification of tumor-associated antigens leading to rational extensions of
 adoptive therapy and vaccination directed against this disease.

 Objectives:

 -  Primary Objective: To obtain tissue, both tumor and lymphocytes, which can be used to
 identify tumor antigens specific to the various histologies of pancreas and ampullary
 cancer along with the HLA restricted epitopes of these antigens.

 -  Secondary Objective: To treat patients with resectable pancreas neoplasms using standard
 pancreatic resection and follow for survival.

 Eligibility:

 -  Any patient greater than or equal to16 years of age with radiographic or endoscopic
 evidence of a pancreatic mass, ampullary mass or malignant stricture without evidence of
 distant metastases

 -  Patients must have an ECOG performance score of 0-2.

 -  Patients must have laboratory and physical examination parameters within acceptable
 limits by standard of practice guidelines prior to biopsy or surgery.

 Design:

 -  A tissue acquisition trial in which tissues will be obtained at the time of surgical
 operation for the resection of pancreas exocrine tumors.

 -  Tissue will be processed by the Surgery Branch Cell processing lab in accordance with
 their standard practices.

 -  No investigational therapy will be given.

 -  It is anticipated that 180 patients will be enrolled over 7 years.
-  INCLUSION CRITERIA

 Any patient greater than or equal to 16 years of age with radiographic or endoscopic
 evidence of a pancreatic mass, ampullary mass or malignant stricture without evidence of
 distant metastases.

 Recovered from any serious toxicity experienced during previous treatment (chemo-,
 radiation, hormone, immuno-, etc., therapy) for pancreas cancer to a grade 2 or less.

 ECOG Performance Status greater 0-2.

 Must have laboratory and physical examination parameters within acceptable limits by
 standard of practice guidelines prior to surgery.