Full Text View
Tabular View
No Study Results Posted
Related Studies
Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
This study is ongoing, but not recruiting participants.
Study NCT00003434   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
June 1998
 
 
 
Complete list of historical versions of study NCT00003434 on ClinicalTrials.gov Archive Site
 
 
 
Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
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

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.

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.

Phase II
Interventional
Treatment
Pancreatic Cancer
  • Biological: carcinoembryonic antigen peptide 1
  • Biological: hepatitis B antigen peptide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
24
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003434
 
CDR0000066460, DUMC-97093, NCI-G98-1457
Duke University
National Cancer Institute (NCI)
Study Chair: Michael A. Morse, MD Duke University
National Cancer Institute (NCI)
June 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP