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
Recruitment status was Recruiting
Sponsor:
Blood Transfusion Centre of Slovenia
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
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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 Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 19, 2013