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

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.

Sponsored by:	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

MedlinePlus related topics:

Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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)

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
	Cancer Care Northwest
	Spokane, Washington, United States, 99218
	University of Washington
	Seattle, Washington, United States, 91895

Sponsors and Collaborators

Epimmune

More Information

Study sponsor home web site This link exits the ClinicalTrials.gov site

Study ID Numbers:	EP2101-101
First Received:	February 12, 2003
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00054899
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epimmune:

vaccine

lung

cancer

Carcinoma, Large Cell

Non-Small-Cell Lung Carcinoma

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Large Cell

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008