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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003434 |
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.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: carcinoembryonic antigen peptide 1 Drug: hepatitis B antigen peptide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 24 |
Study Start Date: | June 1998 |
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 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
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Michael A. Morse, MD | Duke University |
Study ID Numbers: | CDR0000066460, DUMC-97093, NCI-G98-1457 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003434 |
Health Authority: | United States: Federal Government |
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |