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Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma (SYSTHER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01021800
Recruitment Status : Unknown
Verified November 2009 by Blood Transfusion Centre of Slovenia.
Recruitment status was:  Recruiting
First Posted : November 30, 2009
Last Update Posted : January 13, 2010
Information provided by:
Blood Transfusion Centre of Slovenia

Brief Summary:
Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. When included, patients are pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear cells are given.

Condition or disease Intervention/treatment Phase
Pancreatic Tubular Adenocarcinoma Biological: MIS Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Cell infusion Biological: MIS
Cell infusion

Primary Outcome Measures :

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ECOG performance status 0-2 at the time of inclusion
  • Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment

Exclusion Criteria:

  • Pregnancy
  • Less than 3 mths expected survival
  • Serious comorbidity
  • Age above 70 yrs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01021800

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Contact: Borut Stabuc, MD PhD +38615222210
Contact: Lojze Smid, MD

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University Medical Centre Ljubljana, Department for Gastroenterolgy Recruiting
Ljubljana, Slovenia, 1000
Contact: Borut Stabuc, MD, PhD    +38615222210   
Contact: Lojze Smid, MD   
Principal Investigator: Borut Stabuc, MD, PhD         
Sponsors and Collaborators
Blood Transfusion Centre of Slovenia

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Responsible Party: Primoz Rozman, MD PhD, Blood Transfusion Centre of Slovenia Identifier: NCT01021800     History of Changes
Other Study ID Numbers: MIS
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: November 2009
Keywords provided by Blood Transfusion Centre of Slovenia:
Pancreatic tubular adenocarcinoma adjuvant setting
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type