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Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

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.
ClinicalTrials.gov Identifier: NCT00003433
Recruitment Status : Completed
First Posted : August 13, 2003
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to kill their tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with resected liver metastases from colon cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine Phase 1 Phase 2

Detailed Description:


  • Determine the cellular immune response to carcinoembryonic antigen pulsed dendritic cells in patients with adenocarcinoma of the colon metastatic to the liver.
  • Evaluate the overall and recurrence free survival in this patient population.

OUTLINE: Patients undergo leukapheresis for up to 4.5 hours to collect dendritic cells. The separated dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Patients receive CEA RNA pulsed dendritic cells intravenously every 2 weeks for a total of 4 doses. Patients undergo a second leukapheresis 2 weeks after the last dendritic cell infusion to obtain specimens for immunologic tests. Patients with extra doses of dendritic cells available may receive additional doses of CEA RNA pulsed dendritic cells every 2 months in the absence of unacceptable toxicity.

Patients are followed at weeks 12, 24, 36, and 48, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study over 2 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous, Cultured Dendritic Cells After Complete Resection of Hepatic Metastases of Colorectal Carcinoma
Study Start Date : June 1998
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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


  • Histologically confirmed adenocarcinoma of the colon metastatic to the liver that expresses carcinoembryonic antigen (CEA) after resection with curative intent

    • At least 50% of the tumor cells must stain positive for CEA with at least moderate intensity
  • No gross residual disease after surgery



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 6 months


  • Absolute neutrophil count at least 1000/mm 3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL
  • No chronic or acute hepatic disease


  • Creatinine less than 2.5 mg/dL


  • No chronic or acute cardiac disease (New York Heart Association class III or IV)


  • No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease


  • Not pregnant or nursing
  • No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years
  • No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis
  • No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis
  • No active infectious enteritis or eosinophilic enteritis


Biologic therapy:

  • No other concurrent immunotherapy


  • No concurrent chemotherapy
  • At least 6 weeks since prior chemotherapy

Endocrine therapy:

  • No concurrent steroid therapy (or any other immunosuppressives)
  • At least 6 weeks since prior steroid therapy


  • No concurrent radiotherapy
  • At least 6 weeks since prior radiotherapy


  • Recovered from prior surgery

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 ClinicalTrials.gov identifier (NCT number): NCT00003433

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Herbert K. Lyerly, MD Duke Cancer Institute
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ClinicalTrials.gov Identifier: NCT00003433    
Other Study ID Numbers: CDR0000066459
First Posted: August 13, 2003    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: November 2002
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
liver metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes