Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Biological: MelCancerVac

Study type: Interventional

Funder types: Other

Identifiers

NCT00311272

2612-1970

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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