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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00003434
First received: November 1, 1999
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Biological: carcinoembryonic antigen peptide 1
Biological: hepatitis B antigen peptide
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Progression Free Survival [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 1998
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Detailed 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.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00003434     History of Changes
Other Study ID Numbers: 1259, DUMC-97093, NCI-G98-1457, CDR0000066460
Study First Received: November 1, 1999
Last Updated: February 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014