Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT00311272
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-05
• Study Completion: 2007-09
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Surgical Department, University Hospital Gentofte; 🇩🇰 Hellerup, Denmark