An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer

This study has been completed.

First Received: February 12, 2003 Last Updated: April 7, 2008 History of Changes

Sponsored by:	Epimmune
Information provided by:	Epimmune
ClinicalTrials.gov Identifier:	NCT00054912

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 Colon Cancer.

Condition	Intervention	Phase
Colonic Neoplasms Colorectal Neoplasms	Biological: EP2101	Phase I

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 III Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Epimmune:

Estimated Enrollment:	18
Study Start Date:	February 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 Colon Cancer, stage III
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: NCT00054912

Locations

United States, California
University of Southern California School of Medicine
Los Angeles, California, United States, 90033
University of California, San Diego
San Diego, California, United States, 92037
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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	EP2101-102
Study First Received:	February 12, 2003
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00054912 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epimmune:

vaccine
colon
cancer
colorectal

neoplasm
Colonic Cancer
Colon Cancer
Cancer of the Colon

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Rectal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009