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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael A. Morse, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

CDR0000066460

NCT ID:

NCT00003434

Start Date:

June 1998

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710