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

This study has been completed.
Sponsor:
Information provided by:
Epimmune
ClinicalTrials.gov Identifier:
NCT00054912
First received: February 12, 2003
Last updated: April 7, 2008
Last verified: April 2004

February 12, 2003
April 7, 2008
February 2003
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Complete list of historical versions of study NCT00054912 on ClinicalTrials.gov Archive Site
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An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer

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.

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Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colonic Neoplasms
  • Colorectal Neoplasms
Biological: EP2101
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054912
EP2101-102
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Epimmune
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Epimmune
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP