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

Colorectal Neoplasms Clinical Trial

Official title:

An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054912
• Other study ID #: EP2101-102
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2003
• Last updated: April 7, 2008
• Start date: February 2003

Study information

• Verified date: April 2004
• Source: Epimmune
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms
• Neoplasms

Intervention

Biological:
• EP2101

Locations

Country	Name	City	State
United States	New York Oncology Hematology	Albany	New York
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Southern California School of Medicine	Los Angeles	California
United States	Cancer Centers of Florida	Orlando	Florida
United States	University of California, San Diego	San Diego	California
United States	University of Washington	Seattle	Washington
United States	Cancer Care Northwest	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Epimmune

Country where clinical trial is conducted

United States, 

External Links

•   Link