Carcinoembryonic Antigen-loaded Dendritic Cells in Advanced Colorectal Cancer Patients

Induction of Specific T Cell Responses in Colorectal Cancer Patients With Liver Metastases Upon Vaccination With Autologous Dendritic Cells Pulsed With CEA-peptide or Electroporated With CEA-RNA: Evaluation of in Vivo Immune Response.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00228189

Enrollment

Registered

2005-09-28

Start date

2003-12-31

Completion date

2010-11-30

Last updated

2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Liver Metastases

Keywords

Dendritic cells, Colorectal cancer, Carcinoembryonic antigen, Vaccine, Immunotherapy

Brief summary

Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients. We evaluate the ability of mature DCs pulsed with carcinoembryonic antigen (CEA)-peptide (arm A) or electroporated with CEA-mRNA (arm B) to induce CEA-specific T cell responses in patients with resectable liver metastases from colorectal cancer. To evaluate immune responses, CEA-specific T cell reactivity is monitored in peripheral blood, resected abdominal lymph nodes, tumor tissue and biopsies of vaccination sites and post-treatment DTH skin tests. Patients are vaccinated intradermally and intravenously with CEA-peptide pulsed mature DCs three times prior to resection of liver metastases. In 2007 a side-study has been added (arm C), in which patients with stage III or high-risk stage II colorectal cancer that are amenable for standard adjuvant oxaliplatin/capecitabine therapy are vaccinated with CEApeptide-pulsed DCs. Also in this group, safety and immune responses in peripheral blood and the DTH-skin test are the primary endpoints. Results are compared with the results obtained in arm A.

Interventions

BIOLOGICALCEA-loaded dendritic cell vaccine

Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

For arm A and B Inclusion Criteria: 1. Histological documented evidence of colorectal cancer. 2. Primary tumor surgically removed, recurrence(s) in the liver. 3. Planned surgical excision of liver metastases. 4. HLA-A2.1 phenotype according to lymphocyte HLA typing. 5. Expression of CEA on primary tumor. 6. ECOG performance status 0-1, life expectancy \> 3 months. 7. Age 18-75 years. 8. WBC \> 3.0 x 109/l, lymphocytes \> 0.8 x 109/l, platelets \> 100 x 109/l, serum creatinine \< 150 μmol/l, serum bilirubin \< 25 μmol/l. 9. Expected adequacy of follow-up. 10. Written informed consent.

Exclusion criteria

1. Clinical signs of extra hepatic metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this. 2. Prior chemotherapy, immunotherapy, or radiotherapy within three months before planned surgical excision is allowed. 3. A history of myocardial infarction, angina pectoris, cardiac arrhythmias, cerebrovascular accidents, transient ischemic attacks or severe hypertension (

Design outcomes

Primary

Measure	Time frame
immunological response against carcinoembryonic antigen and the control protein KLH	During the study
Toxicity	During the study

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026