Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311272
• Other study ID #: 2612-1970
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2006
• Last updated: February 17, 2009
• Start date: November 2004
• Est. completion date: September 2007

Study information

• Verified date: February 2009
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Biological:
• MelCancerVac

Locations

Country	Name	City	State
Denmark	Surgical Department, University Hospital Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark,