Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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|ClinicalTrials.gov Identifier: NCT00003433|
Recruitment Status : Completed
First Posted : August 13, 2003
Last Update Posted : June 21, 2013
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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|
- 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 :||Interventional (Clinical Trial)|
|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|
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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
- Karnofsky 70-100%
- 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
PRIOR CONCURRENT THERAPY:
- No other concurrent immunotherapy
- No concurrent chemotherapy
- At least 6 weeks since prior chemotherapy
- 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
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
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Herbert K. Lyerly, MD||Duke Cancer Institute|
|Other Study ID Numbers:||
|First Posted:||August 13, 2003 Key Record Dates|
|Last Update Posted:||June 21, 2013|
|Last Verified:||November 2002|
stage IV colon cancer