Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma

Pancreatic Tubular Adenocarcinoma Clinical Trial

— SYSTHER  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01021800
• Other study ID #: MIS
• Status: Recruiting
• Phase: Phase 2
• First received: November 27, 2009
• Last updated: January 12, 2010
• Start date: April 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2009
• Source: Blood Transfusion Centre of Slovenia
• Contact: Borut Stabuc, MD PhD
• Phone: +38615222210
• Email: borut.stabuc[@]kclj.si
• Is FDA regulated: No
• Health authority: Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Tubular Adenocarcinoma

Intervention

Biological:
• MIS
Cell infusion

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana, Department for Gastroenterolgy	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Blood Transfusion Centre of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROGRESSION FREE SURVIVAL		1 YEAR	No