An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00054912 |
Recruitment Status
:
Completed
First Posted
: February 14, 2003
Last Update Posted
: April 9, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colonic Neoplasms Colorectal Neoplasms | Biological: EP2101 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2003 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054912
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 |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00054912 History of Changes |
Other Study ID Numbers: |
EP2101-102 |
First Posted: | February 14, 2003 Key Record Dates |
Last Update Posted: | April 9, 2008 |
Last Verified: | April 2004 |
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 |