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Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer Clinical research trials and Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer. Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer  Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
For Condition: liver metastases,stage 4 colon cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the cellular immune response to carcinoembryonic antigen pulsed dendritic cells in patients with adenocarcinoma of the colon metastatic to the liver. II. Evaluate the overall and recurrence free survival in this patient population. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: - Absolute neutrophil count at least 1000/mm3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm3 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HerbertLyerly, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000066459; DUMC-2031-00-11R3,NCI-G98-1456,DUMC-2176-99-12R2,DUMC-97146
Study Start Date: April 2002
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003433
Other Liver Metastases Studies:
1. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
2. DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
3. Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
4. Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
5. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
Related Studies:
Other liver metastases Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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