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

Phase 1

Completed

• Conditions: Colonic Neoplasms; Colorectal Neoplasms

• Registration Number: NCT00054912
• Lead Sponsor: Epimmune

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 Colon Cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-02-12
• Study First Submitted QC: 2003-02-13
• Study First Posted: 2003-02-14
• Status Verified: 2004-04
• Last Update Submitted: 2008-04-07
• Last Update Posted: 2008-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (9)

New York Oncology Hematology; 🇺🇸 Albany, New York, United States

Mary Crowley Medical Research Center; 🇺🇸 Dallas, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Cancer Care Northwest; 🇺🇸 Spokane, Washington, United States

University of Southern California School of Medicine; 🇺🇸 Los Angeles, California, United States

Cancer Centers of Florida; 🇺🇸 Orlando, Florida, United States

Tyler Cancer Center; 🇺🇸 Tyler, Texas, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States