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

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ClinicalTrials.gov Identifier: NCT00054912
Recruitment Status : Completed
First Posted : February 14, 2003
Last Update Posted : April 9, 2008
Sponsor:
Information provided by:
Epimmune

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Colorectal Neoplasms Biological: EP2101 Phase 1

Study Design
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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
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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