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.
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.
- 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
- 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
- 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
- No active acute or chronic infection such as urinary tract infection, HIV, or viral
- No active infectious enteritis or eosinophilic enteritis Not pregnant or nursing
Fertile patients must use effective contraception
- Biologic therapy: At least 4 weeks since immunotherapy. No other concurrent
- Chemotherapy: At least 4 weeks since chemotherapy and recovered. No concurrent
- 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