NCT00311272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

First QC Date

April 3, 2006

Last Update Submit

February 17, 2009

Conditions

Colorectal Neoplasms

Keywords

dendritic cellsantigens, neoplasm

Interventions

MelCancerVacBIOLOGICAL

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Uncontrolled infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Department, University Hospital Gentofte

Hellerup, 2900, Denmark

Location

Related Publications (2)

  • Burgdorf SK. Dendritic cell vaccination of patients with metastatic colorectal cancer. Dan Med Bull. 2010 Sep;57(9):B4171.

    PMID: 20816019DERIVED

  • Burgdorf SK, Claesson MH, Nielsen HJ, Rosenberg J. Changes in cytokine and biomarker blood levels in patients with colorectal cancer during dendritic cell-based vaccination. Acta Oncol. 2009;48(8):1157-64. doi: 10.3109/02841860903099964.

    PMID: 19863224DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Anders Fischer, MD

    University Hospital Gentofte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

November 1, 2004

Study Completion

September 1, 2007

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

DK(1)