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Surgery for Pancreatic Tumors and Collection of Tumor Tissue for Study

14 december 2019 bijgewerkt door: National Cancer Institute (NCI)

Immunologic Studies of Tumors of the Pancreas

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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

25

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Maryland
      • Bethesda, Maryland, Verenigde Staten, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Udo Rudloff, M.D., National Cancer Institute (NCI)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

21 december 2004

Studie voltooiing

20 november 2012

Studieregistratiedata

Eerst ingediend

28 december 2004

Eerst ingediend dat voldeed aan de QC-criteria

28 december 2004

Eerst geplaatst (Schatting)

29 december 2004

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 december 2019

Laatste update ingediend die voldeed aan QC-criteria

14 december 2019

Laatst geverifieerd

20 november 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 050044
  • 05-C-0044

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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