Back to resultsAn Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
Primary Purpose
Colonic Neoplasms, Colorectal Neoplasms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EP2101
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring vaccine, colon, cancer, colorectal, neoplasm, Colonic Cancer, Colon Cancer, Cancer of the Colon
Eligibility 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
Sites / Locations
- University of Southern California School of Medicine
- University of California, San Diego
- Cancer Centers of Florida
- New York Oncology Hematology
- Duke University Medical Center
- Mary Crowley Medical Research Center
- Tyler Cancer Center
- University of Washington
- Cancer Care Northwest
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00054912
Brief Title
An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
Official Title
An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Epimmune
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Colorectal Neoplasms
Keywords
vaccine, colon, cancer, colorectal, neoplasm, Colonic Cancer, Colon Cancer, Cancer of the Colon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
EP2101
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Southern California School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cancer Centers of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
New York Oncology Hematology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
91895
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.idm-biotech.com
Description
Related Info
Learn more about this trial
An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
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