Dendritic Cell Vaccination in Patients With Advanced Colo... | NCT00311272

Studies
Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

NCT00311272

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Feb 18, 2009Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Colorectal Neoplasms

Interventions

MelCancerVac

Countries

Denmark

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Apr 3, 2006

First Submission Date that Met QC Criteria

Apr 3, 2006

First Posted Date

Apr 5, 2006Estimated

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

Feb 17, 2009

Last Update Posted Date

Feb 18, 2009Estimated

Description Module

Brief Summary

Dendritic cells loaded with tumor antigens induce cytotoxic T-cells which have been proved capable of killing both melanoma and breast cancer cells. Melanoma and colorectal cancer cells express some common antigens. Hence it is possible to use melanoma lysate to load the dendritic cells with tumor antigens similar to the antigens expressed by the patients' colorectal cancer cells.

The patient receives 10 vaccinations with 14 days between each. The parameters for effect are changes in tumor/metastasis size measured with computed tomography (CT), decrease in serum concentration of carcinoembryonic antigen (CEA), performance status measured by the World Health Organization (WHO) criteria, and Quality of Life.

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

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
MelCancerVac	Biological

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Verified cancer of colon or rectum
No chemo- or radiation therapy in 6 weeks
Performance status 0, 1, or 2 (WHO criteria)
Adequate function of the kidneys, liver, lungs, and heart
Adequate function of the hematopoietic system and the coagulation system
Negative pregnancy test and adequate birth control for fertile women

Exclusion Criteria:

Pregnancy
Uncontrolled infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anders Fischer, MD	University Hospital Gentofte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surgical Department, University Hospital Gentofte		Hellerup		2900	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20816019	Derived	Burgdorf SK. Dendritic cell vaccination of patients with metastatic colorectal cancer. Dan Med Bull. 2010 Sep;57(9):B4171.
19863224	Derived	Burgdorf SK, Claesson MH, Nielsen HJ, Rosenberg J. Changes in cytokine and biomarker blood levels in patients with colorectal cancer during dendritic cell-based vaccination. Acta Oncol. 2009;48(8):1157-64. doi: 10.3109/02841860903099964.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D015179	Colorectal Neoplasms
D009369	Neoplasms