An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
This study has been completed.
Sponsor:
Epimmune
Information provided by:
Epimmune
ClinicalTrials.gov Identifier:
NCT00054912
First received: February 12, 2003
Last updated: April 7, 2008
Last verified: April 2004
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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:
Further study details as provided by Epimmune:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
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
No publications provided
| 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 |
ClinicalTrials.gov processed this record on May 21, 2013