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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054899
Recruitment Status : Completed
First Posted : February 14, 2003
Last Update Posted : March 24, 2010
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Lung Neoplasm Biological: EP2101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054899

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

Layout table for additonal information Identifier: NCT00054899     History of Changes
Obsolete Identifiers: NCT00060047
Other Study ID Numbers: EP2101-101
First Posted: February 14, 2003    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: April 2004
Keywords provided by Epimmune:
Carcinoma, Large Cell
Non-Small-Cell Lung Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs