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2004-12-21
N/A
2012-11-20
25
NCT00100321
National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
OBSERVATIONAL
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2004-12-28 | N/A | 2019-12-14 |
2004-12-28 | N/A | 2019-12-17 |
2004-12-29 | N/A | 2012-11-20 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
16 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
