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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. 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)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE August 13, 2003
Last Update Posted Date June 21, 2013
Study Start Date  ICMJE June 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003433 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Metastatic Cancer
Intervention  ICMJE Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00003433
Other Study ID Numbers  ICMJE CDR0000066459
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Duke Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Herbert K. Lyerly, MD Duke Cancer Institute
PRS Account National Cancer Institute (NCI)
Verification Date November 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP