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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Blood Transfusion Centre of Slovenia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Blood Transfusion Centre of Slovenia
ClinicalTrials.gov Identifier:
NCT01021800
First received: November 27, 2009
Last updated: January 12, 2010
Last verified: November 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Primoz Rozman, MD PhD, Blood Transfusion Centre of Slovenia
ClinicalTrials.gov Identifier: NCT01021800     History of Changes
Other Study ID Numbers: MIS
Study First Received: November 27, 2009
Last Updated: January 12, 2010
Health Authority: Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

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

ClinicalTrials.gov processed this record on April 17, 2014