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Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

This study has been completed.

Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003433
  Purpose

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 Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Phase I
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   June 1998

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003433

Locations
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Investigators
Study Chair:     Herbert K. Lyerly, MD     Duke University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066459, DUMC-2031-00-11R3, DUMC-2176-99-12R2, DUMC-97146, NCI-G98-1456
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003433
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer  
liver metastases  

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008




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