Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma

Phase 2

• Conditions: Pancreatic Tubular Adenocarcinoma

• Registration Number: NCT01021800
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Status Verified: 2009-11
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-11-30
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PROGRESSION FREE SURVIVAL	1 YEAR

Trial Locations

Locations (1)

University Medical Centre Ljubljana, Department for Gastroenterolgy; 🇸🇮 Ljubljana, Slovenia