Protocol Number: 05-C-0044

Title:

Immunologic Studies of Tumors of the Pancreas

Number:

05-C-0044

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

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.

Subjects of both genders and all racial/ethnic groups are eligible. Efforts will be made to extend accrual to a representative population.

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 than 3.

Must be willing to sign a durable power of attorney.

Must be willing to sign informed consent. Parents of pediatric patients must be willing to sign informed consent.

Must be willing to return to the NIH for follow up.

Required values for initial laboratory test:

WBC greater than or equal to 2500/ml

ANC greater than or equal to 1000/ml

Platelets greater than or equal to 50 x 10(3)/ml

Creatinine less than or equal to 2.5 mg/dL

HBsAg - negative

HIV - negative

Women of childbearing potential must have a negative urine pregnancy test conducted during screening.

EXCLUSION CRITERIA

Patients with evidence of distant metastatic disease or unresectable disease by CAT criteria (SMA involvement or thrombosed SMV/portal system).

Who are undergoing or have undergone in the past 3 weeks any other form of systemic therapy for their cancer.

Patients with a positive HIV test or who have any form of primary or secondary immunodeficiency (as exhibited by ANC less than 1000 cells/mm(3), or presence of opportunistic infections) will be excluded.

Active infection, this includes positive results from HIV, HBsAg and anti-HCV.

A history of hepatic cirrhosis

Significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as severe congestive heart failure or active ischemic heart disease.

Concurrent second malignancy requiring systemic therapy.

Special Instructions:

Currently Not Provided

Keywords:

Tumor Antigen Identification

Standard Treatment

Tissue Acquisition

Surgery

Adjuvant Chemotherapy

Recruitment Keyword(s):

Pancreatic Cancer

Pancreatic Tumor

Condition(s):

Pancreatic Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26.

Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. Review. No abstract available.

Abbruzzese JL. New applications of gemcitabine and future directions in the management of pancreatic cancer. Cancer. 2002 Aug 15;95(4 Suppl):941-5. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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