An Open Label Study of a Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer

March 23, 2010 updated by: Epimmune

An Open Label, Multi-center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer (NSCLC)

EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Non-Small Cell Lung Cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

18

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
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
    • Florida
      • Orlando, Florida, United States, 32806
        • Cancer Centers of Florida
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Seattle, Washington, United States, 91895
        • University of Washington
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest

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

Inclusion Criteria:

  • Confirmed diagnosis of Non-Small Cell Lung Cancer, stage IIb or IIIa
  • At least four weeks following prior standard treatment, with no evidence of disease
  • Must use adequate birth control

Exclusion Criteria:

  • Prior cancer vaccine therapy or concurrent participation in any other investigational study
  • A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
  • A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
  • Women who are pregnant, intend to become pregnant, or who are breast feeding

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Epimmune

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

January 1, 2003

Study Registration Dates

First Submitted

February 12, 2003

First Submitted That Met QC Criteria

February 13, 2003

First Posted (Estimate)

February 14, 2003

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 23, 2010

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP2101-101

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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