Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

This study has been completed.

First Received: April 3, 2006 Last Updated: February 17, 2009 History of Changes

Sponsored by:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00311272

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms	Biological: MelCancerVac	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Vaccination With Autologous Dendritic Cells Pulsed With Allogenous Melanoma Lysate (MelCancerVac) for Treatment of Patients With Advanced Colorectal Cancer

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Estimated Enrollment:	40
Study Start Date:	November 2004
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311272

Locations

Denmark
Surgical Department, University Hospital Gentofte
Hellerup, Denmark, 2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

Principal Investigator:

Anders Fischer, MD

University Hospital Gentofte

More Information

No publications provided

Study ID Numbers:	2612-1970
Study First Received:	April 3, 2006
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00311272 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:

dendritic cells
antigens, neoplasm

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Melanoma

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009