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

January 12, 2010 updated by: Blood Transfusion Centre of Slovenia
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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Ljubljana, Slovenia, 1000
        • Recruiting
        • University Medical Centre Ljubljana, Department for Gastroenterolgy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Borut Stabuc, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cell infusion
Cell infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PROGRESSION FREE SURVIVAL
Time Frame: 1 YEAR
1 YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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