Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100321
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2004-12-28
Brief Title:
Surgery for Pancreatic Tumors and Collection of Tumor Tissue for Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immunologic Studies of Tumors of the Pancreas
Status:
TERMINATED
Status Verified Date:
2012-11-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-0044 | None | None | None |