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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.

Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003434
  Purpose

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

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Hepatitis B Vaccines    Pancrelipase    Ultrase   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   24
Study Start Date:   June 1998

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003434

Locations
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Investigators
Study Chair:     Michael A. Morse, MD     Duke University    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066460, DUMC-97093, NCI-G98-1457
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003434
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I pancreatic cancer  
stage II pancreatic cancer  
stage III pancreatic cancer  
adenocarcinoma of the pancreas  

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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