An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer - Full Text View

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 1


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 III Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: 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 (Adult, Senior)
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

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, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00054912 History of Changes
Other Study ID Numbers:	EP2101-102
Study First Received:	February 12, 2003
Last Updated:	April 7, 2008
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

Additional relevant MeSH terms:


Neoplasms Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases	Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016