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Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

This study has been completed.
Study NCT00003433.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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
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

OBJECTIVES:

  • 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 Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Colorectal Cancer
Metastatic Cancer
Intervention  Drug: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  June 1998
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 6 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine less than 2.5 mg/dL

Cardiovascular:

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

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No other concurrent immunotherapy

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Recovered from prior surgery
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00003433
Organization ID CDR0000066459
Secondary IDs †† DUMC-2031-00-11R3, DUMC-2176-99-12R2, DUMC-97146, NCI-G98-1456
Study Sponsor  Duke University
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Herbert K. Lyerly, MD     Duke University    
Information Provided By National Cancer Institute (NCI)
Verification Date November 2002
First Received Date  November 1, 1999
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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