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Immunologic Studies of Tumors of the Pancreas


N/A
16 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

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Trial Information

Immunologic Studies of Tumors of the Pancreas


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


- 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Elise C Kohn, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

050044

NCT ID:

NCT00100321

Start Date:

December 2004

Completion Date:

November 2012

Related Keywords:

  • Pancreatic Neoplasms
  • Tumor Antigen Identification
  • Standard Treatment
  • Tissue Acquisition
  • Surgery
  • Adjuvant Chemotherapy
  • Pancreatic Cancer
  • Pancreatic Tumor
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892