Biological Therapy in Stage I, Stage II, or Stage III Surgically Resected Pancreatic Cancer

Study Overview
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Brief Summary
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Rational: 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.

Detailed Description
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Objective: 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. 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. Project Accrual: A total of 24 patients will be accrued for this study over 2 years.

Official Title
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A Pilot Study of Active Immunotherapy With Carcinoembryonic Antigen Peptide-Pulsed, Autologous Human Cultured Dendritic Cells in Patients With Resected, Stage I, II and III Pancreatic Adenocarcinoma Expressing Carcinoembryonic Antigen

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: carcinoembryonic antigen peptide 1
* Biological: hepatitis B antigen peptide


Participation Criteria
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Eligibility Criteria
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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 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 Prior 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: carcinoembryonic antigen peptide 1|nan|
|Biological: hepatitis B antigen peptide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas