Modulation of the Immune Response in Patients With Pancre... | NCT01021800

Studies
Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma

NCT01021800

Sponsor

Blood Transfusion Centre of Slovenia

Status

Unknown status

Last Update Posted

Jan 13, 2010Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Pancreatic Tubular Adenocarcinoma

Interventions

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Nov 27, 2009

First Submission Date that Met QC Criteria

Nov 27, 2009

First Posted Date

Nov 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2010

Last Update Posted Date

Jan 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cell infusion	Experimental		Biological: MIS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MIS	Biological	Cell infusion	Cell infusion

Measure	Description	Time Frame
PROGRESSION FREE SURVIVAL		1 YEAR

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Borut Stabuc, MD PhD	Contact	+38615222210		borut.stabuc@kclj.si
Lojze Smid, MD	Contact			lojze.smid.jr@mf.uni-lj.si

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana, Department for Gastroenterolgy	Recruiting	Ljubljana	Ljubljana	1000	Slovenia