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Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00311272
First received: April 3, 2006
Last updated: February 17, 2009
Last verified: February 2009
History of Changes
  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 2

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

Resource links provided by NLM:

U.S. FDA Resources

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 by University Hospital, Gentofte, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by University Hospital, Gentofte, Copenhagen:
dendritic cells
antigens, neoplasm

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013