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Sponsored by: |
University Hospital, Gentofte, Copenhagen |
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Information provided by: | University Hospital, Gentofte, Copenhagen |
ClinicalTrials.gov Identifier: | NCT00311272 |
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 |
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Colorectal Neoplasms |
Biological: MelCancerVac |
Phase II |
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 |
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Surgical Department, University Hospital Gentofte | |
Hellerup, Denmark, 2900 |
Principal Investigator: | Anders Fischer, MD | University Hospital Gentofte |
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 |
dendritic cells antigens, neoplasm |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Melanoma |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |