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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Blood Transfusion Centre of Slovenia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021800
First Posted: November 30, 2009
Last Update Posted: January 13, 2010
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.
Information provided by:
Blood Transfusion Centre of Slovenia
  Purpose
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 Intervention Phase
Pancreatic Tubular Adenocarcinoma Biological: MIS Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Blood Transfusion Centre of Slovenia:

Primary Outcome Measures:
  • PROGRESSION FREE SURVIVAL [ Time Frame: 1 YEAR ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cell infusion Biological: MIS
Cell infusion

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01021800


Contacts
Contact: Borut Stabuc, MD PhD +38615222210 borut.stabuc@kclj.si
Contact: Lojze Smid, MD lojze.smid.jr@mf.uni-lj.si

Locations
Slovenia
University Medical Centre Ljubljana, Department for Gastroenterolgy Recruiting
Ljubljana, Slovenia, 1000
Contact: Borut Stabuc, MD, PhD    +38615222210    borut.stabuc@kclj.si   
Contact: Lojze Smid, MD       lojze.smid.jr@mf.uni-lj.si   
Principal Investigator: Borut Stabuc, MD, PhD         
Sponsors and Collaborators
Blood Transfusion Centre of Slovenia
  More Information

Responsible Party: Primoz Rozman, MD PhD, Blood Transfusion Centre of Slovenia
ClinicalTrials.gov Identifier: NCT01021800     History of Changes
Other Study ID Numbers: MIS
First Submitted: November 27, 2009
First Posted: November 30, 2009
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:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms