Carcinoembryonic Antigen-loaded Dendritic Cells in Advanced Colorectal Cancer Patients
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ClinicalTrials.gov Identifier: NCT00228189 |
Recruitment Status :
Completed
First Posted : September 28, 2005
Last Update Posted : November 30, 2010
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer Liver Metastases | Biological: CEA-loaded dendritic cell vaccine | Phase 1 Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: A
Dendritic cells pulsed with CEA-peptide
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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
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Biological: CEA-loaded dendritic cell vaccine
Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells. |
- immunological response against carcinoembryonic antigen and the control protein KLH [ Time Frame: During the study ]
- Toxicity [ Time Frame: During the study ]

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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:
- Histological documented evidence of colorectal cancer.
- Primary tumor surgically removed, recurrence(s) in the liver.
- Planned surgical excision of liver metastases.
- HLA-A2.1 phenotype according to lymphocyte HLA typing.
- Expression of CEA on primary tumor.
- ECOG performance status 0-1, life expectancy > 3 months.
- Age 18-75 years.
- 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.
- Expected adequacy of follow-up.
- Written informed consent.
Exclusion Criteria:
- Clinical signs of extra hepatic metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.
- Prior chemotherapy, immunotherapy, or radiotherapy within three months before planned surgical excision is allowed.
- A history of myocardial infarction, angina pectoris, cardiac arrhythmias, cerebrovascular accidents, transient ischemic attacks or severe hypertension (exclusion criteria for autologous blood donation)
- Concomitant use of corticosteroids or other immunosuppressive agents.
- A history of any second malignancy in the past five years excluding adequately treated basal carcinoma of skin or carcinoma in situ of cervix.
- Serious concomitant disease, active infections. Specifically, patients with autoimmune disease or organ allografts and patients with a history of HBsAg or HIV are excluded.
- A known allergy to shell fish.
- Pregnant or lactating women.
For arm C (side-study)
inclusion criteria:
- histological proof of colorectal cancer
- HLA-A0201 positive
- 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)
- ≤ 8 weeks since surgical resection of primary colorectal tumor
- Age 18-75 years
- WHO performance 0-1 (Karnofsky 100-70%)
- WBC ≥ 3.0x109/l
- Platelets ≥ 100x109/l
- Hb ≥ 6 mmol/l
- Total bilirubin ≤ 2x UNL
- ASAT and ALAT ≤ 3x UNL
- Serum creatinine ≤ 1.5 x UNL
- Expected adequacy of follow-up
- Signed written informed consent
exclusion criteria
- 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
- Serious concomitant disease. Autoimmune disease or organ grafts.
- Other serious concomitant diseases preventing the safe administration of study drugs or likely to interfere with the study assessments.
- A known allergy to shell fish (contains KLH)
- Pregnant or lactating women

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 ClinicalTrials.gov identifier (NCT number): NCT00228189
Netherlands | |
Radboud University Nijmegen Medical Center, dept. of Medical Oncology | |
Nijmegen, Netherlands, P.O. box 9101 6500 HB |
Principal Investigator: | Prof. dr. C.J.A. Punt, MD,PhD | Radboud University Nijmegen Medical Center, dept. of Medical Oncology |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | C.J.A. Punt, MD, PhD, Radboud University Nijmegen Medical Centre |
ClinicalTrials.gov Identifier: | NCT00228189 |
Other Study ID Numbers: |
920-03-250 NWO920-03-250 |
First Posted: | September 28, 2005 Key Record Dates |
Last Update Posted: | November 30, 2010 |
Last Verified: | November 2010 |
Dendritic cells Colorectal cancer Carcinoembryonic antigen Vaccine Immunotherapy |
Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |