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Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311272
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : February 18, 2009
Information provided by:
University Hospital, Gentofte, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Biological: MelCancerVac Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Vaccination With Autologous Dendritic Cells Pulsed With Allogenous Melanoma Lysate (MelCancerVac) for Treatment of Patients With Advanced Colorectal Cancer
Study Start Date : November 2004
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311272

Surgical Department, University Hospital Gentofte
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Principal Investigator: Anders Fischer, MD University Hospital Gentofte

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00311272     History of Changes
Other Study ID Numbers: 2612-1970
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009

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

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