Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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MelCancerVac

Intervention Type BIOLOGICAL

Eligibility Criteria

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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