- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003433
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066459
- DUMC-2031-00-11R3
- DUMC-2176-99-12R2
- DUMC-97146
- NCI-G98-1456
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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