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Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed 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 Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed Clinical research trials and Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed 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 Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed. Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed 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 Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed clinical trial. Participants oftentimes recieve the most expert healthcare available for their Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed 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 > "B" Clinical Trials Conditions > Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed  Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
For Condition: stage 2 pancreatic cancer,stage 3 pancreatic cancer,stage 1 pancreatic cancer,adenocarcinoma of the pancreas
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: RATIONALE: White blood cells that have been treated with carcinoembryonic antigen peptide-1 may help the body build an immune response to and kill tumor cells that express CEA. PURPOSE: Phase II trial to study the effectiveness of white blood cells plus carcinoembryonic antigen peptide-1 in treating patients with stage I, stage II, or stage III pancreatic cancer that has been surgically removed.
Details: OBJECTIVES: I. Perform a pilot study of active immunotherapy with autologous dendritic cells pulsed with the CEA peptide, CAP-1, after surgical resection in patients with CEA expressing pancreatic cancer. II. Perform laboratory analysis to monitor the presence, persistence, and function of CAP-1 specific T-cells in this patient population. PROTOCOL OUTLINE: Patients undergo leukapheresis for up to 4.5 hours prior to vaccination. Half of the collected dendritic cells are pulsed with carcinoembryonic antigen (CEA) peptide and the other half are pulsed with hepatitis B antigen peptide (HBsAg). Equal doses of CEA and HBsAg peptide pulsed dendritic cells are administered intravenously over 3 minutes every 4 weeks for a total of 6 doses each. Patients undergo a second leukopheresis 2 weeks after the last dose of immunotherapy to obtain specimens for immunologic tests. Patients are followed at weeks 22, 36, 48, and every 6 months thereafter. PROJECTED ACCRUAL: A total of 24 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 stage I, II, or III adenocarcinoma of the pancreas; Resected with no gross residual disease - At least 50% of tumor cells must be CEA positive and stain with at least moderate intensity - HLA-A2 positive --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since immunotherapy; No other concurrent immunotherapy - Chemotherapy: At least 4 weeks since chemotherapy and recovered; No concurrent chemotherapy - Endocrine therapy: No concurrent corticosteroid or immunosuppressive therapy; At least 6 weeks since steroid therapy - Radiotherapy: At least 4 weeks since radiotherapy and recovered - 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 - Hepatic: Bilirubin less than 2.0 mg/dL; SGOT and alkaline phosphatase less than 4 times the upper limit of normal; No hepatic failure - Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min - Cardiovascular: No New York Heart Association class III or IV heart disease - Pulmonary: No concurrent asthma or chronic obstructive pulmonary disease - Other: No other malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years; No history of autoimmune diseases such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, rheumatoid arthritis, or multiple sclerosis; No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis; No active infectious enteritis or eosinophilic enteritis; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelMorse, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000066460; DUMC-97093,NCI-G98-1457
Study Start Date: June 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003434
Other Stage 3 Pancreatic Cancer Studies:
1. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
2. Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer
3. Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
4. Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
5. Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
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