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

Duke University

Status and phase

Terminated

Phase 1

Conditions

Pancreatic Cancer

Treatments

Biological: carcinoembryonic antigen peptide 1

Biological: hepatitis B antigen peptide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00003434

1259

NCI-G98-1457

DUMC-97093

CDR0000066460 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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