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Carcinoembryonic Antigen-loaded Dendritic Cells in Advanced Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00228189
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : November 30, 2010
Information provided by:
Radboud University Medical Center

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Biological: CEA-loaded dendritic cell vaccine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2003
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Active Comparator: A
Dendritic cells pulsed with CEA-peptide
Biological: CEA-loaded dendritic cell vaccine
Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells.

Experimental: B
Dendritic cells electroporated with CEA-mRNA
Biological: CEA-loaded dendritic cell vaccine
Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells.

Experimental: C
Dendritic cells pulsed with CEA-peptide, in combination with oxaliplatin/capecitabine
Biological: CEA-loaded dendritic cell vaccine
Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells.

Primary Outcome Measures :
  1. immunological response against carcinoembryonic antigen and the control protein KLH [ Time Frame: During the study ]
  2. Toxicity [ Time Frame: During the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (exclusion criteria for autologous blood donation)
  4. Concomitant use of corticosteroids or other immunosuppressive agents.
  5. A history of any second malignancy in the past five years excluding adequately treated basal carcinoma of skin or carcinoma in situ of cervix.
  6. Serious concomitant disease, active infections. Specifically, patients with autoimmune disease or organ allografts and patients with a history of HBsAg or HIV are excluded.
  7. A known allergy to shell fish.
  8. Pregnant or lactating women.

For arm C (side-study)

inclusion criteria:

  1. histological proof of colorectal cancer
  2. HLA-A0201 positive
  3. stage III (T1-4N1-2M0) cancer or high risk stage II (T4 and/or poor differentiation in histology and/or perforation and/or obstruction and/or venous invasion and/or histological analysis of ≤10 lymph nodes)
  4. ≤ 8 weeks since surgical resection of primary colorectal tumor
  5. Age 18-75 years
  6. WHO performance 0-1 (Karnofsky 100-70%)
  7. WBC ≥ 3.0x109/l
  8. Platelets ≥ 100x109/l
  9. Hb ≥ 6 mmol/l
  10. Total bilirubin ≤ 2x UNL
  11. ASAT and ALAT ≤ 3x UNL
  12. Serum creatinine ≤ 1.5 x UNL
  13. Expected adequacy of follow-up
  14. Signed written informed consent

exclusion criteria

  1. A history of second malignancy within the last 5 years. Adequately treated basal carcino¬ma of skin or carcinoma in situ of cervix is acceptable within this period
  2. Serious concomitant disease. Autoimmune disease or organ grafts.
  3. Other serious concomitant diseases preventing the safe administration of study drugs or likely to interfere with the study assessments.
  4. A known allergy to shell fish (contains KLH)
  5. Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00228189

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Radboud University Nijmegen Medical Center, dept. of Medical Oncology
Nijmegen, Netherlands, P.O. box 9101 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
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Principal Investigator: Prof. dr. C.J.A. Punt, MD,PhD Radboud University Nijmegen Medical Center, dept. of Medical Oncology
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: C.J.A. Punt, MD, PhD, Radboud University Nijmegen Medical Centre Identifier: NCT00228189    
Other Study ID Numbers: 920-03-250
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010
Keywords provided by Radboud University Medical Center:
Dendritic cells
Colorectal cancer
Carcinoembryonic antigen
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes