Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Surgical Department, University Hospital Gentofte

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MelCancerVac

Biological

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Vaccination With Autologous Dendritic Cells Pulsed With Allogenous Melanoma Lysate (MelCancerVac) for Treatment of Patients With Advanced Colorectal Cancer

Important dates

Study start: 2004
Study completion: 2007
First posted: Apr 5, 2006
Registry last updated: Feb 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed