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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 12, 2003
Last Updated Date	April 7, 2008
Start Date ^ICMJE	February 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00054912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
Official Title ^ICMJE	An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Colonic Neoplasms Colorectal Neoplasms
Intervention ^ICMJE	Biological: EP2101
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	18
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00054912
Other Study ID Numbers ^ICMJE	EP2101-102
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Epimmune
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Epimmune
Verification Date	April 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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