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

This study has been completed.

First Received on February 12, 2003. Last Updated on March 23, 2010 History of Changes

Sponsor:	Epimmune
Information provided by:	Epimmune
ClinicalTrials.gov Identifier:	NCT00054899

Purpose

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	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Lung Neoplasm	Biological: EP2101	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Epimmune:

Estimated Enrollment:	18
Study Start Date:	January 2003

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054899

Locations

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

Epimmune

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00054899 History of Changes
Obsolete Identifiers:	NCT00060047
Other Study ID Numbers:	EP2101-101
Study First Received:	February 12, 2003
Last Updated:	March 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epimmune:

vaccine
lung
cancer
Carcinoma, Large Cell
Non-Small-Cell Lung Carcinoma

Additional relevant MeSH terms:

Neoplasms
Carcinoma
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

ClinicalTrials.gov processed this record on February 13, 2012