Back to resultsModulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma (SYSTHER)
Primary Purpose
Pancreatic Tubular Adenocarcinoma
Status
Unknown status
Phase
Phase 2
Locations
Slovenia
Study Type
Interventional
Intervention
MIS
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Tubular Adenocarcinoma focused on measuring Pancreatic tubular adenocarcinoma adjuvant setting
Eligibility 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
Sites / Locations
- University Medical Centre Ljubljana, Department for GastroenterolgyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cell infusion
Arm Description
Outcomes
Primary Outcome Measures
PROGRESSION FREE SURVIVAL
Secondary Outcome Measures
Full Information
NCT ID
NCT01021800
First Posted
November 27, 2009
Last Updated
January 12, 2010
Sponsor
Blood Transfusion Centre of Slovenia
1. Study Identification
Unique Protocol Identification Number
NCT01021800
Brief Title
Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma
Acronym
SYSTHER
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Blood Transfusion Centre of Slovenia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Tubular Adenocarcinoma
Keywords
Pancreatic tubular adenocarcinoma adjuvant setting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cell infusion
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MIS
Intervention Description
Cell infusion
Primary Outcome Measure Information:
Title
PROGRESSION FREE SURVIVAL
Time Frame
1 YEAR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Borut Stabuc, MD PhD
Phone
+38615222210
Email
borut.stabuc@kclj.si
First Name & Middle Initial & Last Name or Official Title & Degree
Lojze Smid, MD
Email
lojze.smid.jr@mf.uni-lj.si
Facility Information:
Facility Name
University Medical Centre Ljubljana, Department for Gastroenterolgy
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Borut Stabuc, MD, PhD
Phone
+38615222210
Email
borut.stabuc@kclj.si
First Name & Middle Initial & Last Name & Degree
Lojze Smid, MD
Email
lojze.smid.jr@mf.uni-lj.si
First Name & Middle Initial & Last Name & Degree
Borut Stabuc, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma
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