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

February 7, 2014 updated by: Duke University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression Free Survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael A. Morse, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (ACTUAL)

August 1, 2002

Study Completion (ACTUAL)

August 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 26, 2004

First Posted (ESTIMATE)

April 27, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1259
  • DUMC-97093
  • NCI-G98-1457
  • CDR0000066460 (OTHER: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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